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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00124-1
Product Name/Description Radiometer ABL90Flex analysers running V3.1MR1 or below

ARTG number: 228382
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 17/02/2015
Responsible Entity Radiometer Pacific Pty Ltd
Reason/Issue In December 2014 Radiometer Pacific advised their customers of a potential significant clinical issue with patient results processed on the ABL90Flex analyser if the inlet is left open for more than 30 seconds after aspiration of the patient sample (RC-2014-RN-01365-1).

Although the analyser provides warning sounds and messages the problem can occur after the following sequence of actions:
1. The operator aspirates patient sample A and forgets to close the inlet
2. The inlet is left open for more than 30 seconds before it is closed
3. An operator aspirates patient sample B
In this case the results for patient sample B are affected by this issue.

Radiometer Pacific advised a short term corrective action by providing a warning label for attachment to the analyser. This label provided instructions for action if the inlet has been left open.
Recall Action Recall for Product Correction
Recall Action Instructions A Radiometer Pacific representative will perform a software upgrade to version 3.1 MR3 on your ABL90Flex analyser to correct the issue and to remove the warning label issued as part of the original recall action. The recall for product correction letter will be provided to customers when the correction is carried out onsite. This action has been closed-out on 12/08/2016.
Contact Information 1800 247 254 - Radiometer Pacific