Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobas 8000 Modular Analyzer Series Recalled by Roche Diagnostics Operations, Inc. Due to On cobas c 701 and cobas c 702...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Operations, Inc. directly.
Affected Products
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Quantity: 78 analyzers
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report