Radiometer recalls ABL800 FLEX models 393-800 and 393-801 with UDI (01)05700693938004 due to a power supply defect that could delay critical treatment. Affected units have specific serial numbers.
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Radiometer is recalling two specific models of ABL800 FLEX blood analyzers because a faulty power supply component could cause delays in treatment. This delay might lead to serious health issues like cyanosis, low blood pressure, or cardiac problems.
An incorrect component in the power supply may cause a short circuit, which could delay treatment. This delay might lead to serious health issues such as cyanosis, low blood pressure, or cardiac problems.
Healthcare professionals using the ABL800 FLEX blood analyzers for medical testing are most at risk. Patients relying on these devices for critical diagnostics could be affected if the device malfunctions.
Check for model numbers 393-800 or 393-801 on the device. The unique device identifier (UDI) (01)05700693938004 is also associated with these units. Serial numbers 902-754R2692N002 and 902-754R2692N001 are affected.
Look for model numbers 393-800 or 393-801 on the device.
Reach out to Radiometer Medical ApS for further assistance with the recall.
The recalled models are ABL800 FLEX with model numbers 393-800 and 393-801.
A short circuit in the power supply could delay treatment, potentially leading to cyanosis, low blood pressure, or cardiac issues.
Check for model numbers 393-800 or 393-801, and the unique device identifier (UDI) (01)05700693938004.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1836-2020 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.
