| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00682-1 |
| Product Name/Description |
N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)
(Quality control reagent)
Catalogue Number: OQWU155 Kit Number: 44696, 44800, and 44834
Catalogue Number: OQWU215 Kit Number: 44697
ARTG Number: 178153 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed complaints about Calibration/QC validation issues as well as 'Abnormal Assay Error' flags when using the affected lots. Affected reagent vials and reagent flexes show partial flocculation and share the same production bulk. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is requesting their customers to discontinue use and discard the affected lots. This action has been closed-out on 06/07/2017. |
| Contact Information |
1800 310 300 - Technical Support Center |