| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01192-1 |
| Product Name/Description |
CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions. An in vitro diagnostic medical device (IVD)
Multiple part numbers and batch numbers
ARTG Number: 93126 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
When the affected lot numbers of the control materials are reconstituted, the positive control solution leukocyte results may become negative if the solution is held for more than two hours at temperatures above 25DegC. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to implement. |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |