Radiometer recalls ABL90 FLEX blood analyzers and spare hemolyzer units due to potential measurement errors in blood tests. Affected units may provide inaccurate results for certain blood measurements.
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.
Radiometer is recalling specific models of ABL90 FLEX blood analyzers and spare hemolyzer units because they can give inaccurate blood test results. This could lead to incorrect medical diagnoses if used without proper calibration.
The analyzers have a problem with a specific part called hemolyzer cuvettes that can cause light to be blocked. This leads to measurement errors in blood tests, especially for certain blood components.
Healthcare professionals using the ABL90 FLEX analyzers in labs or point-of-care settings. Patients receiving blood tests with these devices may be at risk of incorrect results.
Check for model number 393-090 on the ABL90 FLEX analyzers and spare part model 902-980. These units were sold between R0526 and R0941 or R0659 and R0977.
Look for model number 393-090 on the ABL90 FLEX analyzers or model 902-980 on spare hemolyzer units.
The analyzers have a problem with hemolyzer cuvettes that can cause light to be blocked, leading to measurement errors in blood tests.
The recall does not specify a remedy, so contact Radiometer Medical ApS for further instructions.
The recall indicates potential measurement errors, but no specific safety risks like injury or death are mentioned.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2139-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2139-2020 from Radiometer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
