Z-1086-2024Class II

The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used...

Name: Z-1086-2024 The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used...
Creator: Quidel Corporation
Published: 2024-01-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-01-03 / Open, Classified / root cause: labeling and UDI

FDA source

Quidel Corporation began a recall of 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... on 2024-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1086-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-03
Posted: 2024-02-14
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: QMN Covid-19 Multi-Analyte Antigen Device
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.
Root cause tag: labeling and UDI
FDA 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 [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.
Quantity in commerce: 312 Kits
Distribution: US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.
Product codes and lots: UDI-DI: 30014613339229. Lot: 709083

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1086-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1086-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-14

Product code QMN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)