Roche recalls specific chemistry analyzers that may produce incorrect test results if configuration settings are changed, affecting clinical testing accuracy.
Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
Roche is recalling certain chemistry analyzers that could give incorrect test results due to configuration settings. This may lead to undetected errors in test results if sample quality is poor.
The analyzers may have changed configuration settings that cause incorrect results in some tests. Poor sample quality can lead to undetected errors because the system doesn't flag discrepancies.
Healthcare facilities using Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801) are most at risk. These analyzers are used for clinical testing in medical labs.
Check for the product names: cobas pro ISE, cobas c 503, or cobas e 801. The serial numbers listed (1925-10, 1931-04, etc.) indicate affected units.
Verify that the analyzers are set to the correct configuration settings as per Roche's guidelines.
No, the recall does not require immediate discontinuation. Healthcare facilities can continue using the analyzers if configuration settings are correct.
The affected models are cobas pro ISE, cobas c 503, and cobas e 801 analytical units.
Check the serial numbers listed: 1925-10, 1931-04, 1931-05, 1931-07, 1937-10, 1938-01, 1942-10.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0755-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0755-2021 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
