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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00623-1
Product Name/Description Radiometer ABL90 Flex blood gas analyser. An in vitro diagnostic medical device (IVD)

All Serial Numbers with software version 3.3 MR1 or lower

ARTG Number: 228382
(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs)
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 24/05/2018
Responsible Entity Radiometer Pacific Pty Ltd
Reason/Issue Radiometer has recently become aware that the ABL90 FLEX in a very rare specific situation can aspirate Calcium solution instead of rinse solution.

The specific situation can occur when the following takes place:
1. The analyser is in ready mode;
2. Operator lifts the inlet and then closes it again, thereby initiating a rinse; and
3. Immediately after lifts the inlet and quickly closes it again.

In this situation, it will lead to several parameters reported incorrectly. Some of the parameters will not have an error message or question mark indicating a problem with the result.
Recall Action Product Defect Correction
Recall Action Instructions Radiometer are advising customers:
1. Inform users of the ABL90 FLEX analyser that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyser flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. Users may re-use the same solution pack;
2. It is recommended that users review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1 stated in the customer letter;

Radiometer will release a software solution (SW V 3.4) which corrects this issue. An updated IFU will also be provided to users upon completion of the software upgrade.

This action has been closed out on 06/04/2020
Contact Information 1800 247 254 - Radiometer