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

FDA device recall Z-1086-2024 · posted 2024-02-14 · Open, Classified

Recall details

Recalling firm

Quidel Corporation

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.

Action taken

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 remaining inventory of the affected lot. Contact Technical Support at customernotifications@quidelortho.com 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QMN

Quantity affected

312 Kits

Distribution

US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.

Date initiated

2024-01-03

Date posted

2024-02-14

Location

Carlsbad, CA