FDANovember 21, 2019device

ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: 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.

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

The hazard

The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.

What to do

FDA enforcement status: Terminated

Brands named

radiometer medical apsradiometerradiometer medical

Recall history

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

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