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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00137-1
Product Name/Description VersaCell connected to IMMULITE 2000/IMMULITE 2000 XPi analysers

Catalogue Number: 10380063

Siemens Reference Number: IMS 14-01

ARTG Number: 174383
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/02/2014
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue There is a potential for incorrect results to be reported when the VersaCell system drops a sample tube during transfer to the IMMULITE 2000/IMMULITE 2000 XPi automation rack under certain specific conditions. This issue only occurs with VersaCell systems that are connected to IMMULITE 2000/2000XPi and does not affect any other analysers that interface with the VersaCell system.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing additional instructions to mitigate the occurrence of incorrect results due to dropped tubes. Investigations into the issue are continuing and customers will be alerted once a solution has been developed. This action has been closed-out on 04/04/2017.
Contact Information 1800 310 300 - Siemens Technical Support Centre