| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00916-1 |
| Product Name/Description |
Human IgM kit for use on SPAPLUS
Item Number: TBSNK012S
Lot Numbers: 400872 and 407480
ARTG Number: 202167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
An investigation by In Vitro Technologies Investigations of specific lots of Human IgM kit for use on SPAPLUS have identified that the calibration stability has decreased in comparison to historical released kits. Users will be able to identify when the calibration is no longer valid, as control values will fall outside of the provided acceptable limits. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The Binding Site recommends the following:
1. Batch sample analysis, when possible;
2. Recalibrate the assay when QC results have deviated outside of the specified range;
3. Contact In Vitro Technologies for any further guidance or additional kit requirements; and
4. Complete the acknowledgement form supplied with the customer letter, even if you do not have any of the affected product, and return it by email to QRA@invitro.com.au
This action has been closed out on 25/09/2018 |
| Contact Information |
1300 552 003 - In Vitro Diagnostics Customer Care |