Reported Aug 25, 2021 · Ongoing
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
OPTI Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OPTI Medical Systems, Inc · 235 Hembree Park Dr · Roswell, GA · 30076-5738
Is this the product you have?
- OPTI SARS-CoV-2 RT-PCR Test
- REF Numbersa) 99-57003 b) 99-57004
- Lot codes and dates
- a) 99-57003
- Lot Numbers
208082081220813 b) 99-57004
- Lot Numbers
2088120901211013
- Amount recalled
- 3552 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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