Radiometer Medical ApS recalls ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usa
Recalled 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.
Hazard / Issue
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Issued by
FDA
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