Recall Z-1086-2024 ยท QMN Covid-19 Multi-Analyte Antigen Device
Quidel Corporation
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.
| Date | Feb 14, 2024 (initiated Jan 3, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 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 remai |
| Quantity | 312 Kits |
| Distribution | US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.