Radiometer recalls ABL800 FLEX blood gas test systems with software versions 6.19 and below due to potential patient mix-up risks. Affected units have model number 393-801 and UDI (01)05700693938011.
Potential risk of patient mix-up on analyzers due to software issues.
Radiometer is recalling blood gas test systems that could mix up patient results due to software issues. This affects specific models with software versions 6.19 and below, which may cause incorrect blood test results.
The software issues could cause patient results to be mixed up, leading to incorrect blood gas measurements. This might result in wrong medical decisions if the test results are used for patient care.
Healthcare professionals using the ABL800 FLEX blood gas test system with software versions 6.19 and below are likely affected. Patients are at risk if the system mixes up their blood test results.
Check for model number 393-801 on the device or the UDI (01)05700693938011. The software version should be 6.19 or lower to be affected.
Look for the software version on the device; affected units have versions 6.19 and below.
If your ABL800 FLEX has model number 393-801 and software version 6.19 or lower, it is affected.
The recall record does not specify a remedy, so contact Radiometer Medical ApS directly for guidance.
The recall indicates a potential risk of patient mix-up, but no specific safety steps are provided in the record.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2494-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2494-2020 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.
