Biomeme recalls SARS-CoV-2 test kits with shorter RPC Buffer shelf life. The buffer stabilizes for two days instead of one week at room temperature. No action needed for users.
The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).
Biomeme is recalling SARS-CoV-2 test kits because the buffer stabilizes for two days instead of one week at room temperature. This change doesn't affect safety but ensures accurate test results over time.
The test kit's buffer solution stabilizes for two days instead of one week when stored at room temperature. This change is due to ongoing stability studies and does not pose a safety risk.
Users of Biomeme SARS-CoV-2 test kits with the specified part number. Those testing for COVID-19 are most affected.
Check for part number 100002824 on the test kit. All lots are affected, with the last kit distributed using the old instructions on September 14, 2021.
The buffer stabilizes for two days instead of one week at room temperature. No action is needed for users.
No action is needed. The change in buffer shelf life does not affect safety.
Part number 100002824 on the test kit.
The last kit distributed with the old instructions was on September 14, 2021.
We’ve drafted a message you can send Biomeme to request your refund or repair — edit it as you like.
Subject: Recall Z-0452-2022 — Biomeme Biomeme Hello, I own a Biomeme that is covered by recall Z-0452-2022 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.
