FDA recall Z-1244-2022
Helena Laboratories, Corp. · Class II · device
Product
V8 Immunodisplacement Kit REF 1803
Reason for recall
Due to microbial growth causing interference with interpretation.
Distribution
U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
Key facts
- Status
- Ongoing
- Initiation date
- 2022-04-06
- Report date
- 2022-06-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Beaumont, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1244-2022