Radiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
Radiometer Medical ApS is recalling ABL90 FLEX Plus analyzers and hemolyzer units because defective cuvettes cause inaccurate blood measurements.
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 causes measurement errors, representing a risk of harm to patients through inaccurate clinical data, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Radiometer Medical ApS is recalling 544 units of ABL90 FLEX Plus analyzers (model no. 393-02) and Spare Part Hemolyzer Units (902-980) with serial numbers R0526 through R0941. The recall covers products distributed worldwide, including the United States.
The recall is due to a defect in the hemolyzer cuvettes, a subcomponent of the optical system used to measure carboxyhemoglobin (ctHb) and its derivatives. A light shunt in the cuvettes prevents some light from passing through the sample, resulting in a perturbed and non-linear absorbance spectrum. This leads to measurement errors in the analyzer's output.
The affected devices are intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings. Users should contact the manufacturer for instructions on how to address the defect.
The recalled product
- Product
- ABL90 FLEX PLUS, model no. 393-02; 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…
- Manufacturer
- Radiometer Medical ApS
- Hazard
- Affected units
- 544
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195
- and Spare Part Hemolyzer Units (902-980): R0526 - R0941
- Model Number 393-092.
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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