Z-0124-2021Class II

Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich...

Name: Z-0124-2021 Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich...
Creator: Quidel Corporation
Published: 2020-09-17
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2020-09-17 / Terminated / root cause: design

FDA source

Quidel Corporation began a recall of Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2... on 2020-09-17. FDA classified it as Class II and gives the reason as "Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0124-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-17
Posted: 2020-10-19
Terminated: 2022-08-09
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.
Root cause tag: design
FDA root cause: Device Design
Action: On 09/17/20, "FIELD CORRECTIVE ACTION CORRECTION" notices dated 09/16/20 were emailed to customers. The firm called customers over the phone to convey the correction information to some customers. Customers were asked to take the following actions: 1) Discontinue the use of affected package inserts. 2) Access the updated instructions for use labeling which can be located by going to quidel.com/docs and selecting the Sofia SARS Antigen FIA Package Insert document. 3) In the event that your facility has used Remel viral transport media products (e.g., M4, M4RT, M6), please contact Quidel Technical Support to discuss your results. 4) Confirm receipt of this notice by returning a signed copy to [email protected] Please feel free to contact Technical Support at [email protected] or by calling 800.874.1517 (in the U.S.) with any questions or concerns that you may have regarding this issue.
Quantity in commerce: 10537
Distribution: U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.
Product codes and lots: 1438900EN00 (03/20) and 1438901EN00 (05/20)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0124-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-19

Product code QKP

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)