Radiometer ABL90 FLEX Analyzers Recalled for Hemolyzer Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX analyzers and spare hemolyzer units because defective cuvettes cause light shunts, leading to inaccurate measurement results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect leads to measurement errors, posing a risk of harm through inaccurate clinical data, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Radiometer Medical ApS is recalling 1,233 units of ABL90 FLEX analyzers (model no. 393-090) and Spare Part Hemolyzer Units (902-980). The affected units were distributed worldwide, including nationwide in the United States and other countries. The recall covers ABL90 FLEX units with serial numbers R0659 through R0977 and Spare Part Hemolyzer Units with serial numbers R0526 through R0941.
The recall is due to a defect in the hemolyzer cuvettes, which are subcomponents of the optical system used to measure carboxyhemoglobin (ctHb) and related derivatives. In affected cuvettes, a light shunt prevents some light from passing through the sample. This results in a perturbed and non-linear absorbance spectrum, causing measurement errors in the analyzer's output.
These devices are intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings. Users should contact Radiometer Medical ApS for instructions on how to address the defect and ensure accurate testing.
The recalled product
- Product
- ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
- Manufacturer
- Radiometer Medical ApS
- Hazard
- Affected units
- 1,233
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Radiometer Medical ApS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Radiometer Medical ApS
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- HighABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
FDA (Devices) · 2024-07-31
- HighRadiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
- HighABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
- HighRadiometer Arterial Blood Sampler recalled due to sterility guarantee loss
FDA (Devices) · 2022-05-25
Same hazard · measurement error
See all →- HighPhilips Evolution Upgrade 1.5T MRI Stiffness Calculation Error
FDA (Devices) · 2026-05-06
- ModeratePhilips MR 7700 MRE Upgrade MRI Equipment Stiffness Value Error Risk
FDA (Devices) · 2026-05-06
- ModeratePhilips MR 7700 MR Elastography device stiffness value error recall
FDA (Devices) · 2026-05-06
- ModeratePhilips SmartPath to Ingenia Elition X MR Elastography Stiffness Value Errors
FDA (Devices) · 2026-05-06
- ModeratePhilips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
FDA (Devices) · 2026-05-06