OPTI SARS-CoV-2 RT-PCR Test Kits Recalled for False Positive Results
OPTI Medical Systems is recalling COVID-19 test kits due to a precipitation issue that may cause false positive results in 5-10% of affected vials. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves diagnostic test inaccuracy with a documented false positive error rate of 5-10%. Although no illnesses or injuries have been reported, inaccurate test results constitute a risk of harm through unnecessary medical interventions or isolation. The recall meets the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OPTI Medical Systems, Inc. is recalling the OPTI SARS-CoV-2 RT-PCR Test (REF Numbers 99-57003 and 99-57004) due to a precipitation issue in the RNA Master Mix component. The affected kits total 3,552 units.
The precipitation issue may cause late Ct reactors, resulting in false positive test results. The firm determined that 5 to 10% of affected vials of RNA Master Mix may produce inaccurate results. No illnesses or injuries have been reported.
The test kits were distributed to healthcare facilities and laboratories in Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, and the Philippines. Affected lot numbers are: REF 99-57003 (lots 20808, 20812, 20813) and REF 99-57004 (lots 20881, 20901, 211013). Users should contact OPTI Medical Systems for replacement or return instructions.
The recalled product
- Product
- OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
- Manufacturer
- OPTI Medical Systems, Inc
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-positive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) 99-57003
- Lot Numbers: 20808
- 20812
- 20813 b) 99-57004
- Lot Numbers: 20881
- 20901
- 211013
Distribution
Distribution scope not specified by the agency.
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