Z-2138-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- November 21, 2019
- Termination Date
- November 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 544
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.
Distribution Pattern
Worldwide distribution - US Nationwide. Also distributed OUS.
Code Information
ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.