| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00520-1 |
| Product Name/Description |
Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (IVD)
Sample Cup Holder used on Immulite/Immulite 1000 Systems
Siemens Material Number: 10385360 (Set 1-50)
Lot number: 15, 16
Microsample Insert used on Immulite 2000 / 2000 Xpi Systems
Siemens Material Number: 10385209 (Set of 15)
Lot number: 18, 19, 20
ARTG Number: 174399 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
The conductive material of the sample cup holders and microsample inserts, which are used to process samples, do not meet specification for facilitating sample level sensing. When sample level sensing is compromised, sample will not be pipetted and the test or tests ordered for the sample will not be run. |
| Recall Action |
Recall |
| Recall Action Instructions |
This issue has been corrected for future lots of sample cup holders and microsample inserts. Siemens is requesting laboratories to cease using the faulty sample cup holders and microsample inserts until unaffected sample receptacles are received. |
| Contact Information |
1800 310 300 Siemens Technical Support Centre |