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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01316-1
Product Name/Description Radiometer ABL800 series with FLEXQ module. An in vitro diagnostic medical device (IVD)

All Serial Numbers

ARTG Number: 228382
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 16/10/2017
Responsible Entity Radiometer Pacific Pty Ltd
Reason/Issue Radiometer has identified that the registration receipt received after placing a sampler in the FLEXQ can be associated with a different sampler if the barcode quality on the receipt has been affected. This issue may occur in the following situation:

1. The analyser is setup to use registration receipts providing a barcode to identify the sampler and thereby the patient result;
2. The sampler is placed in the FLEXQ and a registration receipt is printed from the analyser;
3. The quality of the barcode on the receipt is poor due to improper handling/damage or poor print quality;
4.The registration receipt is later scanned on the analyser to print the result and the analyser misinterprets the barcode; and/or
5. In the event that the misinterpreted barcode matches that of a previous registration receipt printed on that analyser, the damaged registration receipt may be associated with the previous sampler.
Recall Action Recall for Product Correction
Recall Action Instructions Radiometer is advising users who are testing a sampler in the FLEXQ and printing a registration receipt to verify that the patient results and demographic information match. Radiometer is developing a software upgrade to change the registration receipt barcode to a more robust version to remove the possibility of the barcode being misinterpreted. Radiometer will notify users when the upgrade is available.

This action has been closed out on 12/10/2020
Contact Information 1800 247 254 - Radiometer Pacific