🔍 RecallPedia

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

Class I - Dangerous
🏥 Medical Devices Recalled: December 8, 2021 Beckman Coulter Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    All lot numbers.
  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:
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

Product Codes/Lot Numbers:

All lot numbers.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0692-2022

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