🔍 RecallPedia

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Class I - Dangerous
🏥 Medical Devices Recalled: May 19, 2022 Chromsystems Instruments & Chemicals GmbH Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841
  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:
Chromsystems Instruments & Chemicals GmbH
Reason for Recall:
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

Product Codes/Lot Numbers:

Model: 0192; Lot Number: 2821; UDI/DI: 04250317502841

Distribution:

Distributed in: US, NY, OH, CT

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1336-2022

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