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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01306-1
Product Name/Description Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD).

Material Number: 04528123190

Lots affected: All

ARTG Number: 174909
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/10/2016
Responsible Entity Roche Diagnostics Australia Pty Limited
Reason/Issue There is a potential for elevated recoveries from patient samples when using individual c packs of Tina-quant HbA1c Gen.2. This phenomenon has been noticed across multiple lots when the reagent has inadvertently been frozen. This issue may lead to erroneously high HbA1c results.
Recall Action Recall for Product Correction
Recall Action Instructions Users are to ensure the correct storage conditions of +2 to +8 °C are maintained as per IFU and if freezing was suspected, a control measurement should be performed. It was also recommended at this time to perform QC on each reagent cassette. Users are to carry out QC every 24 hr when using the cassette, and with each new cassette. If QC cannot be kept within the specified range, the respective reagent cassette should not be used for further measurement. Consider switching to the Gen.3 reagent which is less susceptible to low temperatures.

This action has been closed out on 7/09/2018.
Contact Information 02 9860 2357 - Roche Diagnostics Australia