FDAMay 11, 2020device

ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.

What to do

FDA enforcement status: Terminated

Brands named

radiometer medical apsradiometerradiometer medical

UPCs

05700693938394

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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