| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00972-1 |
| Product Name/Description |
LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)
Catalogue Number: RC621
Siemens Material Number: 10464336
Lot Number: 3DD007
ARTG Number: 1822774
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing has confirmed customer complaints regarding an upward shift in QC and patient results following calibration with LOCI Cardiac Troponin I Calibrator lot 3DD007. Based on initial internal investigation, Siemens estimates that approximately 40% of the calibrator lot is affected. Internal testing on patient samples demonstrated an average upward shift of 24% range when compared to an unaffected lot. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to immediately discontinue use and discard any remaining inventory from the affected lot. Siemens is recommending to discuss the issues and requirement for retesting with the medical director. The recommendations regarding the need to review previous QC and patient results is limited to samples tested within the past 24 hours. |
| Contact Information |
1800 310 300 - Siemens Technical Support Center |