Roche recalls cobas 8000 modular analyzers with specific serial numbers for potential incorrect test results due to configuration settings. Affected units may not flag poor sample quality, leading to undetected discrepancies in test results.
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 cobas 8000 modular analyzers that may produce incorrect test results due to configuration settings. This could lead to undetected discrepancies in test results when sample quality is poor.
The analyzers may have changed configuration settings that cause incorrect results for certain tests. When sample quality is poor, the system may not flag the issue, leading to undetected discrepancies in test results.
Healthcare facilities using the affected cobas 8000 modular analyzers for clinical testing. Laboratories that have the specific serial numbers listed in the recall are most at risk.
Check if your analyzer is part of the cobas 8000 modular series with the specific serial numbers listed in the recall notice. The serial numbers are detailed in the product description.
Verify if your analyzer has a serial number from the list provided in the recall notice.
The recall affects Roche cobas 8000 modular analyzers with specific serial numbers listed in the product description.
The analyzers may produce incorrect results for certain tests, especially when sample quality is poor, as the system may not flag discrepancies.
No action is required if your analyzer's serial number is not listed in the recall notice.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0754-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0754-2021 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.
