Recall Z-2310-2021— OPTI Medical Systems, Inc

Name: FDA recall Z-2310-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-25

Class II · Ongoing

Class II FDA medical device recall by OPTI Medical Systems, Inc, initiated 2021-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004. Reason: 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..

Recalling firm: OPTI Medical Systems, Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-06-25
Firm location: Roswell, GA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.