Aniara Biophen LMWH Control C4 Recall for Incorrect Instructions
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4 because incorrect versions of the Instructions for Use were packaged.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error rather than a direct physical hazard.
Plain-English summary
Aniara Diagnostica LLC is recalling three units of BIOPHEN LMWH Control C4, REF 224201. The recall involves specific lots, identified as F1701555P4, where the manufacturer packaged incorrect versions of the Instructions for Use into the device product codes.
The affected products were distributed to accounts in Michigan and Pennsylvania. This recall is classified as Class III by the U.S. Food and Drug Administration, indicating that the use of or exposure to the 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 or obtain a replacement.
The recalled product
- Product
- BIOPHEN LMWH Control C4, REF 224201
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
- Affected units
- 3
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)
- Lots F1701555P4
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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