Roche recalls cobas z 480 analyzers for possible false positive results due to dirty lenses. Lab users should check lens cleanliness and follow manufacturer instructions.
Dirty Lens May Cause Invalid or False Positive Results
Roche is recalling cobas z 480 analyzers that may give false positive results if the lens is dirty. This could lead to incorrect test outcomes for medical diagnostics.
Dirty lenses can cause the analyzer to produce false positive results in medical tests. This may lead to incorrect diagnoses if the tests are used for critical health assessments.
Laboratory professionals using the cobas z 480 analyzer for in-vitro diagnostic tests are most at risk. The recall affects all units sold in the U.S.
The cobas z 480 analyzer is used for specific medical tests like BRAF mutations and HPV detection. Check the unit's UDI number: 04015630929016.
Inspect the lens for dirt or debris that could cause false positive results.
The recall is due to dirty lenses potentially causing false positive results in medical tests.
The cobas z 480 analyzer is used for tests like BRAF mutations, HPV, and MRSA detection.
Check the unit's UDI number: 04015630929016. All units sold in the U.S. are affected.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0846-2021 — Roche Roche Hello, I own a Roche that is covered by recall Z-0846-2021 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.
