Radiometer recalls ABL90 FLEX PLUS analyzers and spare hemolyzer units with model numbers 393-02 and 902-980. These devices may give inaccurate blood test results due to a faulty optical component.
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 ABL90 FLEX PLUS blood analyzers and spare hemolyzer units because they can produce inaccurate test results. This affects medical devices used in labs or at the point of care.
The hemolyzer cuvettes in the optical system can cause light to leak through the sample. This leads to measurement errors in blood tests, potentially giving incorrect results.
Healthcare professionals using these analyzers in labs or point-of-care settings. Patients receiving blood tests with these devices may get inaccurate results.
Check for model numbers 393-02 (ABL90 FLEX PLUS) or 902-980 (hemolyzer units) on the device. These were sold from R0526 to R0941 for the ABL90 FLEX PLUS and R0526 to R0941 for the hemolyzer units.
Look for model numbers 393-02 or 902-980 on the device or its packaging.
The analyzers may give inaccurate blood test results due to a faulty optical component in the hemolyzer cuvettes.
The official recall notice does not specify a remedy or action steps beyond checking the model number.
The recall indicates potential measurement errors, but the official notice does not mention serious injury risks.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2138-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2138-2020 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.
