Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPTI SARS-CoV-2 RT-PCR Test Recalled by OPTI Medical Systems, Inc Due to The firm identified a precipitation issue which may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact OPTI Medical Systems, Inc directly.
Affected Products
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Quantity: 3552 kits
Why Was This Recalled?
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.
Where Was This Sold?
Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
About OPTI Medical Systems, Inc
OPTI Medical Systems, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report