Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic Recalled by Roche Molecular Systems, Inc. Due to In rare instances, channel shifted results have been...
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 Molecular Systems, Inc. directly.
Affected Products
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Quantity: 425 instruments
Why Was This Recalled?
In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report