Radiometer Medical ApS recalls ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intende…

Recall date

November 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2138-2020

FDA classification

Class II

Brand / firm

Radiometer Medical ApS

Sold / distributed

Worldwide distribution - US Nationwide. Also distributed OUS.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.