| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00588-1 |
| Product Name/Description |
Asserachrom Von Willebrand Factor (VWF):Collagen (CB). An in vitro diagnostic medical device (IVD).
Reference Number: 00239
Lot Number: 114710(RE)
ARTG Number: 185170 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Following a customer complaint, Stago has investigated and confirmed that Asserachrom VWF:CB lot 114710(RE) gives higher results compared to the other Asserachrom VWF:CB tested lots for samples with a VWF:CB level above 30%. This issue is more pronounced for samples with a VWF:CB level above 50%.
Based on internal testing by Stago, normal samples tested are overestimated by 26% on average (relative deviation). For example: a normal plasma at 134% could be reported at 167%.The pathology samples tested and in particular the type 1 plasmas are overestimated by 38% on average (relative deviation). For example: a type 1 plasma at 56% could be reported at 75%.
The Quality Control (QC) included in the kit does not always detect the issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostica Stago is advising users to stop using and destroy the affected lot according to current local regulations. Replacement kits will be provided.
This action has been closed out on the 25/10/2018. |
| Contact Information |
1800 984 422 - Diagnostica Stago |