Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-2138-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 21, 2019

Date Posted: June 3, 2020

Recall Number: Z-2138-2020

Event ID: 85390

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.

Status: Terminated

Product Quantity: 544

Code Information:

ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.

Distribution Pattern:

Worldwide distribution - US Nationwide. Also distributed OUS.

Voluntary or Mandated:

Voluntary: Firm initiated