SARS-CoV-2 Antigen Test recall
SARS-CoV-2 Antigen Test
Why was SARS-CoV-2 Antigen Test recalled?
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
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?
GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
- Product
- SARS-CoV-2 Antigen Test
- Recalling firm
- Qiagen Sciences LLC
- Quantity
- 1092 boxes of 60 (65,520 e-sticks)
- Distribution
- Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)