FDAFDA · Food and drugs·Recall number Z-2139-2020
ABL90 FLEX, model no. 393-090; 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.
Published June 3, 2020 · Recall initiated: November 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Radiometer Medical ApS
- Distributor
- Worldwide distribution - US Nationwide. Also distributed OUS.
- Lot
- ABL90 FLEX Model no. 393-090: R0659 - R0977 and Spare Part Hemolyzer Units (902-980): R0526 - R0941
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Denmark