FDA-Device2019-04-24Class III
BIOPHEN UFH Control C2, REF 223901
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
14 kits
Manufactured in
7768 Service Center Dr, N/A, West Chester, OH, United States
Products
BIOPHEN UFH Control C2, REF 223901
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1188-2019Don't want to check this manually?
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