Is BIOPHEN UFH Control C2, REF 223901 recalled?

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. Status: Voluntary: Firm initiated Initial Firm Notification: E-Mail Distribution: Distributed to accounts in MI and PA.

Low RiskFDA Device

Aniara Diagnostica LLC: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Agency Publication Date: April 17, 2019

Affected Products

Product: BIOPHEN UFH Control C2, REF 223901

Lot F1700315P7

Lot Numbers:

F1700315P7

Product: BIOPHEN UFH Control C1, REF 224101

Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1

Product: BIOPHEN LMWH Control C4, REF 224201

Lots F1701555P4

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82468

Status: Resolved

Manufacturer: Aniara Diagnostica LLC

Manufactured In: United States

Units Affected: 3 products (14 kits; 41 units; 3 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.