FDA recall Z-1190-2019
Aniara Diagnostica LLC · Class III · device
Product
BIOPHEN LMWH Control C4, REF 224201
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-1190-2019