Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01148-1
Product Name/Description ADVIA Chemistry Halogen Lamp
Siemens Material Number (SMN): 10309448
Affected Lot Numbers: J411, J412, J501, J502, J503, J504, J505, J506

Affected ADVIA Chemistry Systems:

ADVIA 1200
SMN: 10309735, 10470358, Legacy Numbers – 094-A001-02, 094-A001-03, 094-A001-04, 094-A001-05, 094-A001-06

ADVIA 1800
SMN: 10315183, 10322655, 10337372, 10337373, 10337374, 10337375, 10337376

ADVIA 2400
SMN: 10315769, 10816871, 10816872, 10816873, 10816874, 10816875, 10816876

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 30/11/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics is conducting a Recall for Product Correction for the ADVIA Chemistry Halogen Lamp (SMN 10309448) in ADVIA Chemistry systems. Siemens has identified specific lot numbers of the Halogen Lamp that may have a defect that could cause it to fail prematurely.

The potential exists for a delay in testing if the Halogen Lamp fails prematurely. Results are not impacted as the system will become inoperable when this issue occurs. The risk to health is low. Siemens is not recommending a laboratory look back as a result of this issue.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor Siemens is advising users to inspect unused stock and discard affected units. The sponsor will replace the affected units. If the Halogen lamp currently installed in the system fails approximately 100 hours after installation, customers are to contact the sponsor for a replacement. This action has been closed-out on 24/05/2017.
Contact Information 1800 310 300 - Siemens Technical Support Centre