Recall Z-0428-2021 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Quidel Corporation
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
| Date | Sep 25, 2020 |
| Status | Terminated |
| Reason | Due to false positive results. |
| Root cause | Process control |
| Action | On 10/14/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via US Certified mail to customer informing them that a limited number of SARS Antigen FIA test cassettes have an increased potential for false positive results. Customers are instructed to stop using all product from the affected lot and return the unused product to the Recalling Firm for a replacement or issuance of credit fro any unused product. The specific instruction to customers are: 1. Stop using Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 2. Return the attached Verification Form with the amount of produ |
| Quantity | 8,628 kits |
| Distribution | U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.