SARS-CoV-2 Antigen Test
- Company
- Qiagen Sciences Llc
- Recall Initiated
- January 15, 2021
- Terminated
- July 11, 2022
- Recall Number
- Z-0941-2021
- Quantity
- 1092 boxes of 60 (65,520 e-sticks)
- Firm Location
- Germantown, MD
Reason for Recall
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Distribution
Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Lot / Code Info
GTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Root Cause
Under Investigation by firm
Action Taken
On 01/13/2021, Qiagen issued Urgent Medical Device Correction notices to customers via phone and email. Customers were advised to do the following stop using the product and return any remaining product back to Qiagen.
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