| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00201-1 |
| Product Name/Description |
IMMULITE 2000/IMMULITE 2000 XPi water and liquid waste bottles
Siemens Material Numbers: 10291586 and 10291587
ARTG number: 174399 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics is conducting a correction for the IMMULITE 2000 / IMMULITE 2000 XPi Immunoassay Systems water and liquid waste bottles received from May 2013. Siemens has identified that the water and liquid waste bottle assemblies were manufactured with a quality issue. The opening of both bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
This could result in the aspiration straw dislodging from the bottle causing the instrument to aspirate air into the fluidic line potentially resulting in discordant results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions to assist end users to mitigate risk and identify faulty bottle openings. If a faulty bottle is identified end users are requested to contact Siemens for a replacement.
This action has been closed out on 26/09/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |