🔍 RecallPedia

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Class I - Dangerous
🏥 Medical Devices Recalled: May 18, 2022 Radiometer Medical ApS Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011
  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:
Radiometer Medical ApS
Reason for Recall:
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Product Codes/Lot Numbers:

All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1321-2022

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