🔍 RecallPedia

Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Class I - Dangerous
🏥 Medical Devices Recalled: January 9, 2024 Mckesson Medical-Surgical Inc. Corporate Office Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164
  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:
Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall:
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Product Codes/Lot Numbers:

Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1314-2024

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