FDA recall Z-1189-2019
Aniara Diagnostica LLC · Class III · device
Product
BIOPHEN UFH Control C1, REF 224101
Reason for recall
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Distribution
Distributed to accounts in MI and PA.
Key facts
- Status
- Terminated
- Initiation date
- 2019-03-19
- Report date
- 2019-04-24
- Termination date
- 2019-07-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Chester, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2019