—#114234

Product

Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190; Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190; Bicarbonate Liquid 05446376190; Creatinine Jaff¿ Gen.2 05168597190; C-Reactive Protein Gen.3 05172373190; 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.

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

Root cause (FDA determination)

Software design

Action the firm took

On 11/01/2012 an "Urgent Medical Device Correction" notification was sent via UPS Ground (receipt required) to consignees. The device issue was described and recommended actions were provided. A Roche Field Application Specialist will install the new e-barcode during a scheduled visit. Customers also will have an option to install the new e-barcodes themselves, following the instructions provided in the notification. A Software update will be released when available. Customers may contact Technical Support at 1-800-428-2336 for more information.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.

Timeline

Recall initiated: 2012-11-01
Posted by FDA: 2012-12-04
Terminated: 2014-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114234. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.