Reported Jun 3, 2020 · Terminated
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are…
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
ABL90 FLEX PLUSmodel no. 393-02and
- Spare Part Hemolyzer Units (902-980)R0526 -
- R0941 - Product Usageare 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
- Lot codes and dates
- ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and
- Spare Part Hemolyzer Units (902-980)
R0526 - R0941Model Number 393-092
- Amount recalled
- 544
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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