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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00661-1
Product Name/Description Dimension Enzyme II Calibrator (used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)

Product Code: ENZ II CAL

Catalogue Number: DC143

Siemens Material Number (SMN): 10476170

Multiple Lot Numbers and Expiry Dates affected

ARTG Number: 181688
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/05/2016
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics has received complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the affected Dimension Enzyme II calibrator lots. Internal investigation has confirmed that patients, quality control, and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. There is no risk to patients however there may be a delay in results.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens has reassigned the bottle values of all Enzyme II calibrator lots currently in date. Laboratories may expect to observe a downward shift of approximately 8% in QC, patient samples and proficiency testing materials when reassigned bottle values are used for calibration. Siemens recommends recalibration of existing Alanine Aminotransferase (ALTI) flexes and future calibrations using the reassigned calibrator bottle values for lots provided.
A review of previously generated results due to this issue is at the discretion of the laboratory.
This action has been closed on the 14/09/2018
Contact Information 1800 310 300 - Siemens Technical Support Centre