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Aniara Diagnostica LLC recalls BIOPHEN UFH Control C1, REF 224101
Recalled April 24, 2019 · FDA recall Z-1189-2019 · Aniara Diagnostica
Hazard
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. · FDA Class III
Units
41 units
Sold at
Distributed to accounts in MI and PA.
Description
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Product
BIOPHEN UFH Control C1, REF 224101
Manufacturer(s)
Aniara Diagnostica LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →