Recall Z-2138-2020— Radiometer Medical ApS

Name: FDA recall Z-2138-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-21

Class II · Terminated

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2019-11-21, terminated 2024-11-08. It names one FDA 510(k) clearance: K160153. Product: 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.. Reason: 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..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Terminated
Initiated: 2019-11-21
Terminated: 2024-11-08
Firm location: Bronshoj, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K160153 — ABL90 FLEX PLUSRadiometer Medical Aps·cleared 2016-11-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.