Biomeme recalls certain coronavirus test devices that may fail due to a software error causing incomplete testing. Affected units include Franklin Real-Time PCR Thermocyclers with specific model numbers and software version 6.4.3.
Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
Biomeme is recalling specific coronavirus test devices that may not work properly because of a software error. This could lead to inaccurate test results if users try to run tests on these devices.
The software error causes the device to fail before generating results, meaning tests may not complete correctly. This could lead to inaccurate or missing results for coronavirus detection.
Healthcare professionals and labs using the recalled devices may be affected. Those who have purchased the devices with model numbers 1000003 or 1000018 and software version 6.4.3 are most at risk.
Check if your device has model numbers 1000003 (black) or 1000018 (white) and software version 6.4.3. The devices were sold with an Emergency Use Authorization for coronavirus testing.
Verify your device's model number and software version to confirm if it is affected.
No, the recall does not require immediate stop use. Affected users should check their device model and software version.
Software version 6.4.3 is affected.
Look for model numbers 1000003 (black) or 1000018 (white) with software version 6.4.3.
We’ve drafted a message you can send Biomeme to request your refund or repair — edit it as you like.
Subject: Recall Z-0940-2021 — Biomeme Biomeme Hello, I own a Biomeme that is covered by recall Z-0940-2021 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.
