FDA (Devices) recall action 65572

Ortho-Clinical Diagnostics recalled 37 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 37 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 37 pages.

Products: 37
Announced: 2013-11-27
Critical: 0
Units: —

Why these products were recalled

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

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–25 of 37

ModerateFDA (Devices)··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
Distribution
50 states
HighFDA (Devices)··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 CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
Category
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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 81,382 units distributed worldwide.
Product
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slide Dispense cartridges due to slide dispense issues.
Product
VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112724 VITROS AMYL Slides quantitatively measure amylase (AMYL) activity in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 C
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry ALB Slides due to slide dispense issues. The recall affects 16,583 units distributed worldwide.
Product
VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Li Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides due to slide dispense issues.
Product
VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
Category
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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 544 units distributed worldwide.
Product
VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Category
Distribution
50 states
HighFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.
Product
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
Category
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS LAC Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS LAC Slides because slide dispense cartridges may cause dispensing issues.
Product
VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems
Category
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states