Aniara Diagnostica LLC recalls BIOPHEN UFH Control C2, REF 223901
- Recall date
- March 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1188-2019
- FDA classification
- Class III
- Brand / firm
- Aniara Diagnostica LLC
- Sold / distributed
- Distributed to accounts in MI and PA.
Why it was recalled
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
BIOPHEN UFH Control C2, REF 223901
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