Z-0428-2021Class II

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

Name: Z-0428-2021 QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Creator: Quidel Corporation
Published: 2020-09-25
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-09-25 / Terminated / root cause: manufacturing process

FDA source

Quidel Corporation began a recall of QUIDEL Sofia SARS Antigen FIA IVD REF 20374 on 2020-09-25. FDA classified it as Class II and gives the reason as "Due to false positive results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0428-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-25
Posted: 2020-11-06
Terminated: 2024-09-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Product code: PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Reason for recall: Due to false positive results.
Root cause tag: manufacturing process
FDA 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 [email protected]. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.
Quantity in commerce: 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
Product codes and lots: Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0428-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0428-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06

Product code PSZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)