QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Company
- Quidel Corporation
- Recall Initiated
- September 25, 2020
- Terminated
- September 18, 2024
- Recall Number
- Z-0428-2021
- Quantity
- 8,628 kits
- Firm Location
- San Diego, CA
Reason for Recall
Due to false positive results.
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
Lot / Code Info
Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
Root Cause
Process control
Action Taken
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 product that will be returned so a credit may be issued. The customer will be contacted to arrange the return of product and the corresponding credit. 3. Return any unused product from Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 4. In the event that the customer's facility has used this lot number to report patient results, please contact Technical Support at customernotifications@quidel.com. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.