The Recall Desk

Manufacturer

Ortho-Clinical Diagnostics

221 recalls in our database name Ortho-Clinical Diagnostics as the manufacturing or recalling firm.

What the numbers show

Total
221
Critical
0
Severe
10
Most recent
2024-04-03

Of the 221 recalls from Ortho-Clinical Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–200 of 221

  • ModerateFDA (Devices)·Z-0328-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 85,646 units distributed worldwide.

    Product
    VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0296-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ALKP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS ALKP Slides because of slide dispense issues. The recall affects 183,267 units distributed worldwide.

    Product
    VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues. The recall affects 19,438 units distributed worldwide.

    Product
    VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 31,395 units distributed worldwide.

    Product
    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 units distributed worldwide.

    Product
    VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.

    Product
    VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0292-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ACET Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ACET Slides because of slide dispense issues. The recall affects 16,732 units distributed worldwide.

    Product
    VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.

    Product
    VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0309-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0313-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Fe Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Fe Slides due to slide dispense issues. The recall affects 37,525 units distributed worldwide.

    Product
    VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides due to slide dispense issues affecting cartridge functionality.

    Product
    VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CREA Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides due to slide dispense issues. The recall affects 364,752 units distributed worldwide.

    Product
    VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.

    Product
    VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CHE Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CHE Slides because of slide dispense issues. The recall affects 11,135 units distributed worldwide.

    Product
    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0310-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0307-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRBM Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides because of slide dispense issues. The slides are used to measure carbamazepine levels in serum and plasma.

    Product
    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2014·2013-11-27

    Ortho-Clinical Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 6,606 units distributed worldwide.

    Product
    VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 units distributed worldwide.

    Product
    VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0295-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product ALC Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0323-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS SALI Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS SALI Slides because the associated Slide Dispense cartridges have slide dispense issues.

    Product
    VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Ortho-Clinical Diagnostics

in vitro diagnostics company for blood testing

Country
United States
Founded
1994

Official website

Source: Wikidata (Q7104389), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.