🔍 RecallPedia

BIOPHEN UFH Control C2, REF 223901

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2019 Aniara Diagnostica Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot F1700315P7
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Aniara Diagnostica LLC
Reason for Recall:
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

BIOPHEN UFH Control C2, REF 223901

Product Codes/Lot Numbers:

Lot F1700315P7

Distribution:

Distributed in: MI, PA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1188-2019

Related Recalls

BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.

Aniara Diagnostica

Class I - Dangerous

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