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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00471-1
Product Name/Description Dimension Chemistry Wash

Catalogue number: RD701

Siemens material number: 10445052

Lot numbers:
RD23031 - Expiry 29 Apr 2013
RD23111 - Expiry 7 May 2013
RD23241 - Expiry 19 May 2013
RD23311 - Expiry 26 May 2013
RD23391 - Expiry 4 June 2013
RD23461 - Expiry 11 June 2013

ARTG number: 182554
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/05/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens Healthcare Diagnostics has received complaints of Chemistry Wash causing QC and patient sample result shifts on CTNI, LTNI, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461.
Recall Action Recall
Recall Action Instructions Siemens is requesting their customers to discontinue use of all affected lots and to ensure that calibration of assays have been calibrated with unaffected lots.
Contact Information 1800 310 300 - Siemens Technical Support Centre