Radiometer recalls ABL90 FLEX analyzers with E3800 PC units due to internal clock malfunction. Affected units have specific serial numbers and model numbers. No remedy is provided in the recall notice.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Radiometer is recalling ABL90 FLEX analyzers that came with E3800 PC units because of a clock issue. This could affect the accuracy of test results if the clock malfunctions. The recall does not include a fix or return option.
The internal clock in the analyzers can malfunction, potentially leading to inaccurate blood test results. This issue is specific to units with the E3800 PC installed and does not cause immediate physical harm.
Healthcare professionals using the ABL90 FLEX analyzer with E3800 PC units are most at risk. Patients using these analyzers for blood tests may be affected if the clock issue causes inaccurate results.
Check for the model number ABL90 FLEX (393-090) on the device. Affected units have serial numbers starting with R0996, R1000, or R1003 onwards.
Identify the model number on the device, which should be ABL90 FLEX (393-090).
Check the serial number, which starts with R0996, R1000, or R1003 onwards for affected units.
The recall notice does not provide a remedy or fix for the affected units.
The affected model is ABL90 FLEX (393-090) with specific serial numbers starting with R0996, R1000, or R1003 onwards.
The recall states the issue is a clock malfunction that could affect test accuracy, but does not indicate a risk of serious injury.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1856-2021 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1856-2021 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.
