OPTI Medical Systems, Inc OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Brand
OPTI Medical Systems, Inc
Lot Codes / Batch Numbers
a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
Products Sold
a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
OPTI Medical Systems, Inc is recalling OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
/The firm disseminated a technical bulletin beginning on 06/25/2021 by email identifying the /problem and providing additional instructions to be implemented when using the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CT, FL, GA, IL, ME, NJ, NY, PA, PR
Page updated: Jan 10, 2026