OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Reported: August 25, 2021 Initiated: June 25, 2021 #Z-2310-2021
Product Description
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.
Details
- Recalling Firm
- OPTI Medical Systems, Inc
- Units Affected
- 3552 kits
- Distribution
- Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
- Location
- Roswell, GA
Frequently Asked Questions
What product was recalled? ▼
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004. Recalled by OPTI Medical Systems, Inc. Units affected: 3552 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2310-2021.
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