| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00465-1 |
| Product Name/Description |
VITROS Performance Verifier I for unconjugated bilirubin (Bu)
Product Code: 8067324
AUST L 25922
Lot numbers: A3823, C4084, Q2961, T3161, V3297, X3569
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have been performed by Ortho Clinical Diagnostics to investigate and address an increase in customer complaints generated for low outside the Range of Means PV level I results on multiple VITROS Bu reagent lots and multiple VITROS PV lots. Review of the customer complaints indicate that some customers are observing results that are outside the Range of Means (ROM), within 0.1 mg/dL of the low end.
The differences observed in Bu Range of Means capabilities are not clinically significant and the accuracy of the patient sample results is not impacted by this situation, however there is potential for results to be delayed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
New Assay Sheets containing the revised Range of Means for Bu have been made available on the VITRIOS website. This action has been closed-out on 02/05/2017. |
| Contact Information |
1800 032 359 Customer Technical Services |