QUIDEL Sofia SARS Antigen FIA IVD recall
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Why was QUIDEL Sofia SARS Antigen FIA IVD recalled?
Due to false positive results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number 20374 Lot Number: 706142 UPC A GTIN-12: 0 14613 33908 2 Cassettes: 168365 through 166817
- Product
- QUIDEL Sofia SARS Antigen FIA IVD REF 20374
- Recalling firm
- Quidel Corporation
- Quantity
- 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
- Recall date
- November 18, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)