[Recalled] OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 — The firm identified a precipitation issue which may cause late Ct reactors (a f… | FDA 2021-06-25
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 |
|---|---|
| Brand / manufacturer | OPTI Medical Systems, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2310-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 June 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from OPTI Medical Systems, Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.