🔍 RecallPedia

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

Class I - Dangerous
🏥 Medical Devices Recalled: July 31, 2024 Beckman Coulter Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
  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:
Beckman Coulter Inc.
Reason for Recall:
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

Product Codes/Lot Numbers:

Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

Distribution:

Distributed in: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0118-2025

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Beckman Coulter

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