Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00849-3
Product Name/Description Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). An in vitro diagnostic medical device (IVD)

Catalogue Number: DF105A

Lot Numbers: GA3169, GA3162, GA3141, GA3134, GA3113 & GA3099

ARTG Number: 181689
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/08/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens has received complaints of inaccurate results after calibration of HB1C (DF105A). Accuracy shifts of up to 27%, both high and low, have been reported on QC and patient samples. The shift observed with QC material is consistent with the direction and magnitude of the shift observed with patient samples.
Recall Action Recall for Product Correction
Recall Action Instructions End user to use updated scaler values for calibration of all affected lots.
Contact Information 1800 310 300 - Siemens Technical Supoprt Centre