Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

BIOPHEN UFH Control C2 Recalled by Aniara Diagnostica LLC Due to The manufacturer packaged incorrect versions of the Instructions...

Date: March 19, 2019
Company: Aniara Diagnostica LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aniara Diagnostica LLC directly.

Affected Products

BIOPHEN UFH Control C2, REF 223901

Quantity: 14 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: MI, PA

Affected (2 states)Not affected

About Aniara Diagnostica LLC

Aniara Diagnostica LLC has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report