Radiometer recalls specific ABL800 Flex analyzers with software versions below V6.19 MR2 due to potential bias in blood test results for certain analytes.
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Radiometer is recalling ABL800 Flex analyzers with model numbers 393-800 and 3:93-801, and those with software versions below V6.19 MR2. This recall is due to a potential for inaccurate blood test results for certain analytes, which could affect medical diagnoses.
The analyzer may produce positive and negative biases for certain blood tests when configured with specific analyte settings (cNa+, cCa+, and cK+). This could lead to incorrect blood test results, potentially affecting medical decisions.
Healthcare facilities using the recalled ABL800 Flex analyzers for blood testing may be affected. Patients receiving blood tests with these devices could experience inaccurate results.
Check for model numbers 393-800 or 393-801 on the device. Also, verify if the software version is below V6.19 MR2. The device may have a unique identifier (UDI/DI) starting with 05700693938004 or 05700693938011.
Verify the software version on the device; if it is below V6.19 MR2, it is affected.
Reach out to Radiometer Medical ApS for guidance on next steps and potential remedies.
This recall affects blood tests using cNa+, cCa+, and cK+ analyte settings on the ABL800 Flex analyzer.
Check for model numbers 393-800 or 393-801, or a unique identifier (UDI/DI) starting with 05700693938004 or 05700693938011. Also, ensure the software version is below V6.19 MR2.
No, but you should check the software version and contact Radiometer for guidance if your device is affected.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1321-2022 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1321-2022 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.
