Aniara Diagnostica Recalls BIOPHEN UFH Control C1 Due to Incorrect Instructions
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1 because incorrect versions of the Instructions for Use were packaged into specific lots.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation error (incorrect instructions) rather than a physical defect or contamination.
Plain-English summary
Aniara Diagnostica LLC is recalling 41 units of BIOPHEN UFH Control C1, REF 224101. The recall involves specific lots (F1700314P2, F1700314P3, F1700314P4, F1801638P1) that were distributed to accounts in Michigan and Pennsylvania.
The recall was initiated because the manufacturer packaged incorrect versions of the Instructions for Use into these specific lots for three device product codes. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for instructions on how to return the product.
The recalled product
- Product
- BIOPHEN UFH Control C1, REF 224101
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots F1700314P2
- F1700314P3
- F1700314P4
- F1801638P1
Distribution
Part of a larger recall action
This product is one of 3 recalled by Aniara Diagnostica LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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