Radiometer Medical ApS recalls The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained…
What should I do?
Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.
What's the hazard?
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
What's affected
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.
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