Roche recalls a small number of cobas Liat analyzer units with high noise levels causing false positive Influenza B results. Affected units have specific serial numbers and material numbers.
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
Roche is recalling a small number of cobas Liat analyzer units that may produce false positive results for Influenza B due to high background noise. This could lead to incorrect test outcomes if the device is used without the issue being addressed.
The amber detector in some units produces high background noise, which increases the chance of false positive Influenza B results. This means the test might incorrectly indicate Influenza B when it's not present.
Users of the cobas Liat analyzer with specific serial numbers and material numbers are affected. Healthcare professionals using the device for respiratory virus testing are most at risk.
Check if your cobas Liat analyzer has the Material Number 07341920190 or the listed serial numbers (16333, 16454, etc.). The device was sold with specific identifiers that can be verified against the provided list.
Verify your cobas Liat analyzer's Material Number and serial numbers against the list provided in the recall notice.
Check if your device has Material Number 07341920190 or the listed serial numbers (16333, 16454, 16688, etc.).
The recall notice does not specify a remedy or action for affected devices.
The recall describes a risk of false positive results, not physical injury or harm.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-0828-2022 — Roche Roche Hello, I own a Roche that is covered by recall Z-0828-2022 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.
