ProductGuru Recalls

Official recall record

The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocaps

US FDA — Medical Devices · 2024-01-03 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2024-01-03
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
30014613339229
Brand on record
Quidel Corporation
Product category
Medical Device

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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