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 specific model numbers and UDI codes.
Potential risk of patient mix-up on analyzers due to software issues.
Radiometer is recalling blood gas test systems (ABL800 FLEX) that use software versions 6.19 and older. This could cause patient mix-ups during testing, which might lead to incorrect results and potential health risks.
Software issues in versions 6.19 and below may cause the system to mix up patient samples, leading to incorrect blood gas and pH test results. This could result in misdiagnosis or inappropriate treatment decisions.
Healthcare providers using the ABL800 FLEX blood gas test system with software versions 6.19 or older are most at risk. Patients receiving tests from these systems could experience incorrect results.
Check for model number 393-800 on the device, software version 6.19 or older, and UDI code (01)05700693938004. The system may be configured as ABL835, ABL830, or other variants listed in the recall notice.
Look for the software version on the device; versions 6.19 or older are affected.
Reach out to Radiometer Medical ApS for guidance on next steps if you have the affected software version.
Software versions 6.19 and below are affected.
Check for model number 393-800, software version 6.19 or older, and UDI code (01)05700693938004.
No, but you should check the software version and contact Radiometer if needed.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-2493-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-2493-2020 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.
