| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01050-1 |
| Product Name/Description |
Panbio Q Fever IgM ELISA (An in vitro diagnostic medical device (IVD))
Catalogue number: 06PE20
Lot number: 264006
ARTG number: 212569 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer’s internal investigations of the lot number listed above have indicated kit degradation during stability monitoring, thus affecting the performance of the kit prior to kit expiry. One Customer complaint has also been received relating to this issue. Due to the instability of the serum used in manufacturing the positive control and calibrator, the values of positive control, calibrator and cut-off were out of specification. The fluctuating values could lead to a potential risk of false positive/false negative results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Alere is requesting their customers to immediately discontinue use of this lot and dispose of any remaining affected product and is providing refund for the unused kits.
Alere is recommending that a review of the previously reported results be undertaken.
Alere is discontinuing this product and requesting the users to investigate an alternative method of testing Q fever. This action has been closed-out on 06/06/2016. |
| Contact Information |
07 3363 7711 - Alere Technical Support |