FDA recall Z-1021-2023
Biokit, S.A. · Class II · device
Product
biokitHSV-2 Rapid Test, REF: 300028001
Reason for recall
HSV-2 rapid test may report false positive results.
Distribution
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-09-28
- Report date
- 2023-02-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Llica D'Amunt, N/A, Spain
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1021-2023