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U.S. Department of Health and Human Services

Class 2 Device Recall Sofia 2 Flu SARS Antigen FIA

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 Class 2 Device Recall Sofia 2 Flu SARS Antigen FIAsee related information
Date Initiated by FirmJanuary 03, 2024
Date PostedFebruary 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1086-2024
Recall Event ID 93799
Product Classification COVID-19 Multi-Analyte Antigen Device - Product Code QMN
ProductThe Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
Code Information UDI-DI: 30014613339229. Lot: 709083
Recalling Firm/
Manufacturer		 Quidel Corporation
2285 Rutherford Rd
Carlsbad CA 92008-8815
Manufacturer Reason
for Recall		One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 1/3/24, correction notices were emailed to customers and distributors who were asked to do the following: 1) Complete and return the attached Confirmation of Notification form to via fax at 858.203.9297 or email at customernotifications@quidelortho.com 2) Indicate the amount of product to be replaced on the Confirmation of Notification form. You are not required to take any action related to already used kit material and can continue to use this lot number until replacement product arrives. 3) Upon receipt of the replacement product, discontinue using, render unusable and discard the remaining inventory of the affected lot. Contact Technical Support at customernotifications@quidelortho.com or by calling 800.874.1517 (in the U.S.) with any questions or concerns that you may have regarding this issue. In addition distributors were asked to do the following: Provide your list of affected customers that received this lot number. Please include a contact name, email, and phone number for each consignee. Once this list is received, the recalling firm will notify all customers on your behalf, collate responses, and facilitate replacements directly.
Quantity in Commerce312 Kits
DistributionUS Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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