| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00874-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD).
Product Code: 6800598
Lot Numbers: 0860, 0870, 0880, 0890, 0908
ARTG Number: 251956 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics have received customer complaints that the signal/cutoff (s/c) results have increased when using the negative control. Their investigation confirmed that results generated using these lots of negative controls had a positive shift in mean results (s/c) as the product approached its open-reconstituted 5 day limit. Increased results (s/c) may also be observed with the positive control.
This issue is isolated to VITROS HBsAg Controls. Patient sample results generated using VITROS Immunodiagnostic Products HBsAg/HBsAg ES Reagents are not affected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics is advising users to discontinue using and discard the affected lots. If you do not have an alternative unaffected lot, continue using the affected lot(s) following these instructions:
- Control results must be within acceptable limits on the day of reconstitution (Day 1).
- Store open-reconstituted vials frozen for up to 4 weeks. We recommend that you aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used.
- Upon receipt of replacement order, discard all remaining inventory. This action has been closed-out on 22/02/2017. |
| Contact Information |
1800 032 359 - Ortho Technical Support Centre |