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U.S. Department of Health and Human Services

Class 2 Device Recall Sofia SARS Antigen FIA

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  Class 2 Device Recall Sofia SARS Antigen FIA see related information
Date Initiated by Firm September 17, 2020
Create Date October 19, 2020
Recall Status1 Terminated 3 on August 09, 2022
Recall Number Z-0124-2021
Recall Event ID 86276
Product Classification Coronavirus antigen detection test system. - Product Code QKP
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.
Code Information 1438900EN00 (03/20) and 1438901EN00 (05/20)
Recalling Firm/
Manufacturer		 Quidel Corporation
10165 McKellar Ct
San Diego CA 92121-4201
For Additional Information Contact
858-552-1100 Ext. 7922
Manufacturer 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.
FDA Determined
Cause 2		 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 customernotifications@quidel.com Please feel free to contact Technical Support at customernotifications@quidel.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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