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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00331-1
Product Name/Description Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers

Catalogue Numbers: 10488062 and 10708128

ARTG Number: 179939
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/03/2014
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue The manufacturer of the analyser, Sysmex Corporation, has informed Siemens Healthcare Diagnostics about an issue potentially affecting the Factor VIII results. The Factor VIII Chromogenic assay generates a curve from which a percentage result is calculated. The Sysmex CS-2100i and CS-5100 Automated blood coagulation analysers may generate an irregular curve that under certain circumstances could lead to an erroneously increased result with a Factor VIII Chromogenic assay. The irregular curve is not flagged by the system.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is advising their customers to run all Factor VIII Chromogenic assays in duplicate and confirm results in conjunction with the patient's clinical history. A software update is expected to be completed mid-2014 to correct the issue.

Update July 2018: Siemens has released a new Protocol Disc Version with revised assay applications on Sysmex CS-2000i, CS-2100i, CS-2500 and CS5100 systems to resolve this issue. Siemens will implement the respective applications to analysers during the next service visit. An updated application sheet will also be provided to users.

This action has been closed out on 24/09/2019
Contact Information 1800 369 598 - Siemens Technical Support Centre