Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Recalled by Roche Diagnostics Operations, Inc. Due to Roche COBAS INTEGRA 800 system, Software Version 9864.C2...
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 INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
Quantity: 527 units
Why Was This Recalled?
Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof
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