FDA-Device2020-06-03Class II
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.
Radiometer Medical ApS
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.
Sold states
Worldwide distribution - US Nationwide. Also distributed OUS.
Affected count
544
Manufactured in
Akandevej 21, N/A, Bronshoj, N/A, Denmark
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2020Don't want to check this manually?
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