Radiometer ABL90 FLEX Analyzers Recalled for Inaccurate Results
Radiometer Medical ApS is recalling ABL90 FLEX and ABL90 FLEX PLUS analyzers due to a risk of potentially inaccurate results requiring updated instructions for use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to a risk of potentially inaccurate results requiring changes to instructions for use. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Radiometer Medical ApS is recalling 5,395 units of the ABL90 FLEX and ABL90 FLEX PLUS analyzers. These in vitro diagnostic devices are intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings under a physician's order. The recall covers software versions 3.6 and lower, as well as specific versions of the Instructions for Use.
The recall is being conducted because the analyzers had a risk of potentially inaccurate results. This risk necessitates changes to the instructions for use regarding sample types, reportable ranges for some parameters, analyzer configuration, and limitations and warnings. Specifically, whole blood samples are no longer suitable for testing FHbF and ctBil.
The affected units were distributed nationwide across the United States, including in 50 states and the District of Columbia. The source text does not report any illnesses, injuries, or deaths associated with this recall. Users should stop using the affected analyzers and contact the manufacturer for further instructions.
The recalled product
- Product
- The ABL90 FLEX and ABL90 FLEX PLUS analyzers 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. These tests are only performed under a physician's order.
- Manufacturer
- Radiometer Medical ApS
- Hazard
- Affected units
- 5,395
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)
- UDI-DI: 05700693930923
- Version: 202606O. ABL90 FLEX Instructions for Use versions prior to: 996-189
- Version: 202606L
Distribution
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