Important Safety Alerts

Medical device manufacturer, Radiometer, has issued a medical device safety alert concerning its ABL90 FLEX (393-090) analyzers running software versions 3.3 MR1 or lower.

The manufacturer has become aware that the ABL90 FLEX in a very rare specific situation can aspirate Cal 2 solution instead of rinse solution. The specific situation can occur 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

In this situation, it will lead to several parameters reported wrong during the following measurements. Some of the parameters will not have an error message or question mark indicating a problem with the result. The wrong reporting will continue until the analyzer flow selector has reset.

According to the manufacturer, the flow selector will reset as part of the automatic error removal process performed during repeated automatic calibrations, QC measurements or during installation of the solution pack. It will release a new software version 3.4 (933-470) for the ABL90 FLEX analyzer, which correct this issue.

The affected customers are advised to take the following actions:

• Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this is done anyway the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described in the Instruction For Use for installation of a solution pack. Re-use the same solution pack.
• Review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1 of the Field Safety Notice.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 21 May 2018.