OPTI Medical Systems recalls specific SARS-CoV-2 test kits due to potential false positives in RNA Master Mix vials. Affected lots may show inaccurate results.
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
OPTI Medical Systems is recalling two specific test kit models because a precipitation issue in some vials can cause false positive results. This means the test might incorrectly show a positive result when the person is not infected.
The test vials can develop a precipitation issue that causes false positive results in 5-10% of cases. This means the test might incorrectly indicate a positive result when the person is not infected, leading to unnecessary anxiety or actions.
People who purchased the OPTI SARS-CoV-2 RT-PCR Test kits with REF numbers 99-57003 or 99-57004 and the listed lot numbers are affected. Those using the test for home testing are most at risk of inaccurate results.
Check the reference number on the test kit: 99-57003 or 99-57004. Look for specific lot numbers listed: 20808, 20812, 20813 for REF 99-57003 and 20881, 20901, 211013 for REF 99-57004.
Verify the reference number and lot numbers to confirm if your test kit is affected.
The recall is due to a precipitation issue in some RNA Master Mix vials that can cause false positive results in 5-10% of cases.
Check the reference number and lot numbers to confirm if your test kit is affected. If it is, you may need to use a different test kit.
The false positive rate is 5-10% for affected vials of RNA Master Mix.
We’ve drafted a message you can send OPTI Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2310-2021 — OPTI Medical Systems OPTI Medical Systems Hello, I own a OPTI Medical Systems that is covered by recall Z-2310-2021 from OPTI Medical Systems. 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.
