Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
FDA Recall Z-0473-2013 · Posted 2012-12-04
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2012-11-01
Date Terminated2014-01-08
Product Quantity78 analyzers
Reason for Recall
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
Firm Action
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.
Root Cause
Software design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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