| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00792-1 |
| Product Name/Description |
Panbio Q Fever IgM ELISA. An in vitro diagnostic medical device (IVD)
Catalogue number: 06PE20
Lot Number: 264005
ARTG number: 212569 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer’s internal investigations of the lot number listed above indicate a decrease in the OD (Optical Density) of the Calibrator affecting the performance of the kit over a period of time resulting in inappropriate treatment. Results of confirmative testing were found to show increased false positives. The values of calibrator and positive control were out of specification (manufacturing range). |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is requesting their customers to immediately discontinue use and destroy all remaining units of the recalled lot. Replacement product is expected to be available in approximately 3 – 4 weeks. Until that an alternate method of testing Q-Fever should be investigated. This action has been closed-out on 03/06/2016. |
| Contact Information |
07 3363 7711 - Alere Technical Support |