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 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…
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 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…
Category
Distribution
50 states
ModerateFDA (Devices)··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
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product 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 AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
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…
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.
Product
VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
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…
Category
Distribution
50 states
ModerateFDA (Devices)··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…
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS BUN/UREA Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS BUN/UREA Slides because of slide dispense issues. The recall affects units distributed worldwide.
Product
VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS…
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 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
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…
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 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 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…
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.
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…
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…
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 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…
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…
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…
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
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…
Category
Distribution
50 states
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
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