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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01115-1
Product Name/Description HemoCue HbA1c 501 Test Cartridge. An in vitro diagnostic medical device (IVD)

Lot Number: F14K12K21DL

ARTG Number: 206986
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 16/11/2015
Responsible Entity Radiometer Pacific Pty Ltd
Reason/Issue The manufacturer has advised that some of the HbA1c501 test cartridges may give elevated results. As the HbA1c501 is used to provide the average glucose concentration over a period of time for patient management and not immediate treatment, an elevated result would not impact patient management.
Recall Action Recall
Recall Action Instructions Radiometer is advising users to discard any remaining stock. This action has been closed-out on 18/08/2016.
Contact Information 1800 247 254 - HemoCue Product Manager