Life Technologies recalls The TaqPath RT-PCR COVID-19 Kit software v1.2 due to risk of false negatives and positives. Affected units may need retesting or correction.
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
Life Technologies is recalling a specific version of their COVID-19 test software because it can cause false negative results (leading to missed infections) and false positives (due to improper vortexing). This means some tests might not detect the virus or incorrectly show infection when there isn't one.
The software version 1.2 may produce false negative results (missing infections) or false positives (showing infection when none exists) due to improper vortexing. This can lead to incorrect test outcomes and increased retesting needs.
Healthcare providers using the specific software version for COVID-19 testing are most at risk. The recall affects labs and clinics that use the software with the TaqPath RT-PCR kit.
Check for the software version 1.2 labeled on the kit packaging. The recall covers units sold with the software version 1.2 from April 28, 2020, through May 19, 2020.
Look for the software version number on the kit packaging to confirm if it's version 1.2.
The software version 1.2 may cause false negative results (missing infections) or false positives due to improper vortexing, leading to incorrect test outcomes.
No, the recall does not require stopping use. The software can be updated to a newer version if available.
Check the software version on the packaging. If it's version 1.2, contact Life Technologies for guidance on updating or correcting the software.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-2978-2020 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-2978-2020 from Life Technologies. 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.
