Recall Z-0941-2021— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2021-01-15, terminated 2022-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: SARS-CoV-2 Antigen Test. Reason: QIAGEN has become aware of the potential for false positive results to occur with some patient samples..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-15
- Terminated
- 2022-07-11
- Firm location
- Germantown, MD, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.