| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01345-1 |
| Product Name/Description |
Liaison Biotrin Control Parvovirus B19 IgM
Part Number: 317011
Lot Numbers: 130010X, 130010X/1, 130012X, 130012X/1 & 130012X/2 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigation confirmed that the Certificates of Analysis of the Liaison Biotrin Control Parvovirus B19 IgM (P/N 317011), lot numbers 130010X, 130010X/1, 130012X, 130012X/1 & 130012X/2, are reporting an incorrect Negative Control range for the LIAISON XL application, when used in combination with Liaison Biotrin Parvovirus B19 IgM (317010) kit lots numbers 129019X & 129019X/1. The Negative Control range for these lots of Liaison Biotrin Control Parvovirus B19 IgM should be 0.0 - 0.5 Index instead of 0.0 - 0.3 Index as previously reported in the incorrect Certificate of Analysis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
DiaSorin has notified their customers of the change to the range of the Liaison Control for Biotrin Parvovirus B19 IgM. |
| Contact Information |
1300 259 835 - DiaSorin Australia |