Radiometer ABL90 FLEX 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?

Check if you have this product:
Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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 Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Product Codes/Lot Numbers:

Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1856-2021

Related Recalls

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.

Radiometer Medical ApS

Class I - Dangerous

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

Mar 21, 2025 Diagnostic Equipment Nationwide View Details →

ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.

Radiometer Medical ApS

Class I - Dangerous

Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

May 31, 2024 Diagnostic Equipment Nationwide View Details →

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.

Radiometer Medical ApS

Class I - Dangerous

Due to potential software issue that may result in patient mix-up information.

Mar 8, 2023 Diagnostic Equipment Nationwide View Details →