Class 2 Device Recall OPTI SARSCoV2 RTPCR Test

• Date Initiated by Firm: June 25, 2021
• Create Date: August 17, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2310-2021
• Recall Event ID: 88344
• Product Classification: Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
• Product: OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
• Code Information: a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013
• Recalling Firm/ Manufacturer: OPTI Medical Systems, Inc; 235 Hembree Park Dr; Roswell GA 30076-5738
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: /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.
• Quantity in Commerce: 3552 kits
• Distribution: Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.