OPTI SARS-CoV-2 RT-PCR Test — Class II medical device recall Z-2310-2021
Ongoing recall by OPTI Medical Systems, Inc, reported 2021-08-25, distributed in AL, CT, FL, GA, IL, ME, NJ, NY…. The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a ra
| Recall number | Z-2310-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OPTI Medical Systems, Inc, Roswell, GA, United States |
| Recall initiated | 2021-06-25 |
| Classified | 2021-08-17 |
| Reported by FDA | 2021-08-25 |
| Distributed | AL, CT, FL, GA, IL, ME, NJ, NY, PA, PR |
| Countries outside the US | BB, CR, HK, PH |
| Quantity | 3,552 kits |
| Lot numbers | 20808, 20812, 20813, 20881, 20901, 211013 |
Product
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2310-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.