| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01286-1 |
| Product Name/Description |
Liaison Biotrin Parvovirus B19 IgM (testing kit), An in vitro diagnostic medical device (IVD)
Catalogue number: 317010
Batch / serial number: 129014X, 129014X/1
Expiration Date: 7 April 2013
Batch / serial number: 129015X, 129015X/1
Expiration Date: 28 May 2013
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
DiaSorin has become aware that the kit lots identified have a potential to produce an increased rate of positive results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
DiaSorin is asking users to retest all initially reactive specimens unless these samples have already been confirmed by another method. Affected lots may still be used to confirm results that are initially reactive by a different method. |
| Contact Information |
1300 259 835 - DiaSorin Australia |