FDA recall Z-0941-2021
Qiagen Sciences LLC · Class II · device
Product
SARS-CoV-2 Antigen Test
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
Key facts
- Status
- Terminated
- Initiation date
- 2021-01-15
- Report date
- 2021-02-10
- Termination date
- 2022-07-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Germantown, MD, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2021