Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation
Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or lost samples.
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 risk-of-harm product where the hazard (patient mixup/delayed treatment) is a direct consequence of a functional defect, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Radiometer Medical ApS is recalling the ABL90 FLEX PLUS Analyzer, Model Number 393-092. The recall involves 3,968 units distributed worldwide, including across the United States and numerous international countries. The affected units are those running software versions below 3.4 MR2.
The recall was initiated after the firm received reports that the analyzer's barcode reader misinterpreted the contents of locally printed barcode labels used for entering patient IDs or accession numbers. This malfunction could result in patient mixups or the loss of samples, which may lead to delayed medical treatment.
The product is intended for use in laboratory, near-patient, or point-of-care settings. Users should verify their software version and contact the manufacturer for instructions on updating the software or replacing the device.
The recalled product
- Product
- ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 3,968
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 (1)
- All software versions below 3.4 MR2
Distribution
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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