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