| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00358-1 |
| Product Name/Description |
Panbio Dengue IgM Capture ELISA, An in vitro diagnostic medical device (IVD)
Catalogue numbers: E-DEN01M / E-DEN01M05
Lots: 12306, 12348 & 13007
ARTG Number: 22341 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Alere have received complaints of invalid test runs due to results falling outside the cut-off value customer acceptance range leading to an invalid test. Analysis of retained kits and customer results has indicated that the invalid test runs are due to the customer acceptance range being inappropriately assigned for these batches. The effect of the inappropriate acceptance range is that a greater number than normal of test results will be considered invalid, requiring the test to be repeated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is providing updated reference values for the affected kits. |
| Contact Information |
07 3363 7711 - Alere Technical Support |