Biomeme recalls its SARS-CoV-2 test due to false positive results from software errors. Users should stop using the test immediately to avoid incorrect health decisions.
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Biomeme is recalling its SARS-CoV-2 test kit because software issues can cause false positive results. This means the test might incorrectly show infection when there isn't one, leading to unnecessary health concerns.
The test software has a bug that causes it to incorrectly flag positive results when the test is run. This happens due to a technical issue with the color change in the test process, leading to false positives.
People who purchased the Biomeme SARS-CoV-2 test kit with the Franklin thermocycler and Biomeme Go mobile app are affected. Those using the test for home testing are most at risk of false positives.
Check for the Biomeme SARS-CoV-2 Real-Time RT-PCR Test kit with the Franklin thermocycler and Biomeme Go mobile app. The product was sold with specific Android smartphones (model 1000013 or 1000012) and the software version from March 24, 2020.
The test may give false positive results, so stop using it immediately to avoid incorrect health decisions.
The software has a bug that causes false positive results, which can lead to incorrect health decisions.
Check for the Biomeme SARS-CoV-2 Real-Time RT-PCR Test kit with the Franklin thermocycler and Biomeme Go mobile app. The product was sold with specific Android smartphones (model 1000013 or 1000012) and the software version from March 24, 2020.
The recall record does not mention a fix or remedy for the software issue.
We’ve drafted a message you can send Biomeme to request your refund or repair — edit it as you like.
Subject: Recall Z-0513-2021 — Biomeme Biomeme Hello, I own a Biomeme that is covered by recall Z-0513-2021 from Biomeme. 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.
