Aniara Recalls BIOPHEN UFH Control C2 Due to Incorrect Instructions
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2 because incorrect Instructions for Use were packaged with the product.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation error (incorrect instructions) rather than a defect in the device itself.
Plain-English summary
Aniara Diagnostica LLC is recalling 14 kits of BIOPHEN UFH Control C2, Reference 223901, Lot F1700315P7. The recall was initiated because the manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
The affected products were distributed to accounts in Michigan and Pennsylvania. The source text does not specify the exact nature of the errors in the instructions or whether any adverse events have occurred.
Consumers and healthcare providers with this specific lot number should stop using the product and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- BIOPHEN UFH Control C2, REF 223901
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
- Affected units
- 14
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 (1)
- Lot F1700315P7
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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