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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00998-1
Product Name/Description	IMMULITE /IMMULITE 1000 Osteocalcin Control Module (Clinical chemistry hormones). An in vitro diagnostic medical device (IVD) Catalogue Number: LONCM Siemens Material Number: 10385415 Control Lot Number: 0022 Kit Lots: 313 and above ARTG Number: 179720
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/09/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics has identified an increase in the mean values obtained with the LONCM control lot 0022 when used with IMMULITE/IMMULITE 1000 Osteocalcin (LKON1, SMN 10361396) kit lots 313 and above. Siemens is providing revised control targets and ranges.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing work around instructions for users to implement.
Contact Information	1800 310 300 - Siemens Technical Support Centre