| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00042-1 |
| Product Name/Description |
STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.
Ref: 00518
ARTG: 185170 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostica Stago has confirmed that the STA - Liatest vWF: Ag assay may produce falsely low results when testing some QC and patient samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stago are advising users to confirm all results obtained in the abnormal range (under 50%) with a manual rerun or by the creation of a dependant test at a 1:2 dilution until a corrective action has been determined. If tests are already performed in duplicate, the requirement for follow up testing should be at the discretion of the laboratory manager. |
| Contact Information |
+61 (0)408 324 608 -Diagnostica Stago Technical Support Manager |