Life Technologies recalls specific versions of their COVID-19 test software due to potential false negatives and false positives, which could lead to inaccurate test results and increased retesting.
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 certain versions of their COVID-19 test software that may produce false negative or false positive results. This could lead to inaccurate test outcomes and unnecessary retesting for users.
The software versions v2.0 and v2.2 may cause false negative results (missing infections) or false positives (showing infection when none exists) due to improper vortexing during testing. This can lead to incorrect test outcomes and increased retesting needs.
Healthcare providers using the recalled software versions for COVID-19 testing are most at risk of inaccurate results. Patients relying on these tests may face incorrect diagnoses.
Check for product SKUs 100093765 (v1.2 EUA), 100087427 (v2.2 EUA), 100093771 (v1.2 CE-IVD), or 100094318 (v2.2 CE-IVD) on the software packaging. The software is used with QuantStudio Real-Time PCR platforms for COVID-19 testing.
Verify the software version on your packaging to see if it matches the recalled SKUs listed in the recall notice.
The affected software versions are v2.0 and v2.2 with SKUs 100093765 (v1.2 EUA), 100087427 (v2.2 EUA), 100093771 (v1.2 CE-IVD), and 100094318 (v2.2 CE-IVD).
The recall is due to potential false negative and false positive results from improper vortexing during testing, which could lead to inaccurate test outcomes.
No, the recall does not require immediate discontinuation; users should check their software version and update if necessary.
We’ve drafted a message you can send Life Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-2979-2020 — Life Technologies Life Technologies Hello, I own a Life Technologies that is covered by recall Z-2979-2020 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.
