Reported Dec 12, 2012 · Terminated
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Road · Indianapolis, IN · 46256-1025
Is this the product you have?
- Cobas 8000 Modular Analyzer Series
- Model/Catalog/Part Number05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190 2 Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190 3 Bicarbonate Liquid 05446376190 4 Creatinine Jaff¿ Gen.2 05168597190 5 C-Reactive Protein Gen.3 05172373190 6 and Urea/BUN 05171873190. Serial Number(s): 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05, 1031-09, 1032-09, 1032-10, 1033-04, 1033-05, 1107-06, 1109-02, 1109-03, 1111-07, 1111-08, 1112-02, 1112-04, 1115-06, 1115-07, 1115-08, 1115-10, 1117-04, 1117-07, 1118-02, 1126-02, 1126-03, 1126-04, 1127-01, 1127-02, 1127-06, 1127-07, 1138-03, 1138-04, 1139-04, 1139-05, 1139-06, 1140-02, 1140-03, 1140-04, 1140-05, 1140-10, 1141-08, 1141-09, 1142-02, 1142-03, 1142-04, 1143-01, 1143-02, 1143-03, 1143-04, 1143-05, 1143-06, 1144-05, 1146-04, 1146-05, 1146-06, 1146-07, and 1146-08. - Amount recalled
- 78 analyzers
Where it was sold
Why it was recalled
On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (C
This product could cause temporary or reversible health problems — stop using it.
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