FDA Recall
Terminated
SARS-CoV-2 Antigen Test
Recall: Z-0941-2021
·
Initiated January 15, 2021
Recall
- Recall Number
- Z-0941-2021
- Event Number
- 87205
- Firm
- Qiagen Sciences LLC
- FEI Number
- 3003572099
- Product Code
- QKP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 15, 2021
- Terminated
- July 11, 2022
- Address
- 19300 Germantown Rd, Germantown, MD, 20874-1415
Description
SARS-CoV-2 Antigen Test
Reason
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Action
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.
Distribution
Domestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Quantity
1092 boxes of 60 (65,520 e-sticks)