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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01192-1
Product Name/Description CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions. An in vitro diagnostic medical device (IVD)

Multiple part numbers and batch numbers

ARTG Number: 93126
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 23/11/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue When the affected lot numbers of the control materials are reconstituted, the positive control solution leukocyte results may become negative if the solution is held for more than two hours at temperatures above 25DegC.
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 Customer Care Centre