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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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