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.
What this means for you
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Aniara Diagnostica LLC
See all →- ModerateAniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
FDA (Devices) · 2026-08-12
- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- Moderate5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- ModerateZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
FDA (Devices) · 2026-05-20
- ModerateBIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
FDA (Devices) · 2023-03-15
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02