FDA Medical Device Recalls (openFDA)
Quidel Corporation: QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Recall number
- Z-0428-2021
- Recalling firm
- Quidel Corporation
- Product
- QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Status
- Terminated
- Initiated
- 2020-09-25
- Posted
- not on file
- Terminated
- 2024-09-18
- 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 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.
- 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
- Lot, serial or model codes
- Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PSZ
- Firm FEI
- 2024674
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28