🔍 RecallPedia

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Class I - Dangerous
🏥 Medical Devices Recalled: October 29, 2020 Chromsystems Instruments & Chemicals GmbH Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)
  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:
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Classification:
Class I - Dangerous

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

Status:
completed

Product Information

Full Description:

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Product Codes/Lot Numbers:

Order No. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0522-2021

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