Recall Z-0941-2021 ยท QKP Coronavirus Antigen Detection Test System.
Qiagen Sciences LLC
SARS-CoV-2 Antigen Test
| Date | Jan 15, 2021 |
| Status | Terminated |
| Reason | QIAGEN has become aware of the potential for false positive results to occur with some patient samples. |
| Root cause | Under Investigation by firm |
| 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.