Sofia recallZ-1086-2024 · Quidel Corporation · initiated Jan 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quidel Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
On 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 [email protected] 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 [email protected] 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.
Recall details
- Recall number
- Z-1086-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 3, 2024
- Posted by the FDA
- Feb 14, 2024
- Recalling firm
- Quidel Corporation
- Quantity
- 312 Kits
- Product code
- QMN
- Distribution
- US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
Product description
The 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 (models, lots, serial numbers)
UDI-DI: 30014613339229. Lot: 709083
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sofia 20377Quidel Corporation · COVID-19 Multi-Analyte Antigen Device1 recall3,284 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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