Recall Z-0428-2021— Quidel Corporation
Class II · Terminated
Class II FDA medical device recall by Quidel Corporation, initiated 2020-09-25, terminated 2024-09-18. FDA's recall record names no specific 510(k) clearance for this event. Product: QUIDEL Sofia SARS Antigen FIA IVD REF 20374. Reason: Due to false positive results..
- Recalling firm
- Quidel Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-25
- Terminated
- 2024-09-18
- Firm location
- San Diego, CA, United States
Product description
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Reason for recall
Due to false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.