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Terminated

QUIDEL Sofia SARS Antigen FIA IVD REF 20374

FDA Recall Z-0428-2021 · Posted None

Recalling FirmQuidel Corporation
Recall StatusTerminated
Product CodePSZ
Date Initiated2020-09-25
Date Terminated2024-09-18
Product Quantity8,628 kits

Reason for Recall

Due to false positive results.

Firm Action

On 10/14/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via US Certified mail to customer informing them that a limited number of SARS Antigen FIA test cassettes have an increased potential for false positive results. Customers are instructed to stop using all product from the affected lot and return the unused product to the Recalling Firm for a replacement or issuance of credit fro any unused product. The specific instruction to customers are: 1. Stop using Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 2. Return the attached Verification Form with the amount of product that will be returned so a credit may be issued. The customer will be contacted to arrange the return of product and the corresponding credit. 3. Return any unused product from Sofia SARS Antigen FIA, Cat. #20374, Lot 706142. 4. In the event that the customer's facility has used this lot number to report patient results, please contact Technical Support at [email protected]. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.

Root Cause

Process control

Distribution Pattern

U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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