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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01022-1
Product Name/Description IMMULITE 1000, 2000, 2000 XPi - IGF-I Control Module (Used for the detection of insulin like Growth Factor hormone). An in vitro diagnostic medical device (IVD)

Catalogue number: LGCOCM

Material number: 10385387

Lot numbers: 025L, 0025 & 0026

ARTG Number: 179720
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 10/10/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens Healthcare Diagnostics confirmed the following:
· a negative bias against the mean values obtained with the LGCOCM control lot 0026 level 2 when used with IMMULITE®/IMMULITE® 1000 (LKGF1, SMN 10381403) kit lots 322 and above
·an increase of mean values obtained with the LGCOCM control lots 0025, 025L, and 0026 when used with IMMULITE® 2000/IMMULITE® 2000 XPi IGF-I (L2KGF2, SMN 10381448) kit lots 486 and 487.
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