🔍 RecallPedia

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Class I - Dangerous
🏥 Medical Devices Recalled: April 14, 2021 Radiometer Medical ApS Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards
  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:
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Product Codes/Lot Numbers:

Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1857-2021

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AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

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