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

26–37 of 37

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 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
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 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
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 4600
Category
Distribution
50 states
ModerateFDA (Devices)··2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.
Product
VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated S
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 Integrate
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 Chem
Category
Distribution
50 states
ModerateFDA (Devices)··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
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 S
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 Integrat
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 a
Category
Distribution
50 states