FDA-Device2019-04-24Class III
BIOPHEN LMWH Control C4, REF 224201
Aniara Diagnostica LLC
Hazard
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Sold states
Distributed to accounts in MI and PA.
Affected count
3 units
Manufactured in
7768 Service Center Dr, N/A, West Chester, OH, United States
Products
BIOPHEN LMWH Control C4, REF 224201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1190-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief