Radiometer recalls ABL90 FLEX analyzers with software versions 3.3MR1 or below due to potential incorrect test results from aspirating Cal 2 solution instead of rinse solution during specific use patterns.
The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again
Radiometer is recalling ABL90 FLEX analyzers with software versions 3.3MR1 or older. These devices can sometimes mix up test solutions, leading to inaccurate blood test results if used in certain ways.
The analyzer can aspirate Cal 2 solution instead of rinse solution when the operator lifts the inlet and quickly closes it again while the device is in ready mode. This mix-up causes incorrect test results for blood components like pH and glucose.
Lab technicians and healthcare providers using the ABL90 FLEX analyzers with software versions 3.3MR1 or below are most at risk of inaccurate test results. Patients receiving blood tests from these devices may get incorrect results.
Check if your ABL90 FLEX analyzer has software version 3.3MR1 or older. The device is a portable blood analyzer used in labs or point-of-care settings.
Contact Radiometer America Inc to update the software to version 3.3MR2 or newer to fix the issue.
The ABL90 FLEX analyzers with software versions 3.3MR1 or below can aspirate Cal 2 solution instead of rinse solution during specific use patterns, leading to inaccurate test results.
Contact Radiometer America Inc to update the software to version 3.3MR2 or newer to fix the issue.
The device is safe to use with proper software updates, but older software versions can cause inaccurate test results.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-0010-2019 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-0010-2019 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.
