OPTI SARS-CoV-2 RT-PCR Test Recall: False Positive Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62301-opti-sars-cov-2-rt-pcr-test-recall-false-positive.
Source Summary by GovInfoNow · govinfonow.com/recall/62301-opti-sars-cov-2-rt-pcr-test-recall-false-positive · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2310-2021
Cite this page
“OPTI SARS-CoV-2 RT-PCR Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62301-opti-sars-cov-2-rt-pcr-test-recall-false-positive. Based on FDA recall #Z-2310-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2310-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
OPTI Medical Systems- Category
Medical device
What to do — step by step
Check Test Kit Details
Verify the reference number and lot numbers to confirm if your test kit is affected.
Where it went and when
Where it was distributed
Distributed in 8 states and Puerto Rico, and outside the U.S.
FDA distribution: “Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Connecticut, Florida, Illinois, Maine, New Jersey, New York, Pennsylvania, Puerto Rico.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2310-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2310-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.