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U.S. Department of Health and Human Services

Class 2 Device Recall Sofia SARS Antigen Fluorescent Immunoassay (FIA)

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  Class 2 Device Recall Sofia SARS Antigen Fluorescent Immunoassay (FIA) see related information
Date Initiated by Firm September 25, 2020
Create Date November 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-0428-2021
Recall Event ID 86550
Product Classification Devices detecting influenza A, B, and C virus antigens - Product Code PSZ
Product QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Code Information Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817 
Recalling Firm/
Manufacturer		 Quidel Corporation
10165 McKellar Ct
San Diego CA 92121-4201
For Additional Information Contact Ronald H. Lollar
740-589-3373
Manufacturer Reason
for Recall		 Due to false positive results.
FDA Determined
Cause 2		 Process control
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 customernotifications@quidel.com. Technical Support will conduct an analyzer log data review to determine if any reported patient results were impacted.
Quantity in Commerce 8,628 kits
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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