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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01028-1
Product Name/Description IMMULITE 2000 / IMMULITE 2000 XPi ACTH Control module (Used for the detection of Adrenocorticotropic hormone). An in vitro diagnostic medical device (IVD)

Catalogue Number: LACCM

Lot Number: 0018

Siemens Material Number: 10385382
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 10/10/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue It has been confirmed that there is a tendency for an increase in the mean values obtained with the LACCM control lot 0018 when used with IMMULITE 2000/IMMULITE 2000 XPi kit lots 240 and above.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing work around instructions for users to follow.
Contact Information 1800 310 300 - Siemens Technical Support Centre