Recall Z-1086-2024— Quidel Corporation

Class II FDA medical device recall by Quidel Corporation, initiated 2024-01-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..

Recalling firm

Quidel Corporation

Classification

Class II

Status

Ongoing

Initiated

2024-01-03

Firm location

Carlsbad, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.