| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00427-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)
VITROS NT-proBNP Calibrators
Product Code: 6802157
GTIN: 10758750002078
VITROS NT-proBNP Reagent Pack
Product Code: 6802156
GTIN: 10758750002061 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Internal testing by Ortho-Clinical Diagnostics, Inc. (OCD) has determined the need for revisions to the low end of the measuring range for the Assay. This revision affects the Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantification (LoQ) and Reportable Measuring Range. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho-Clinical Diagnostics, Inc. (OCD) is providing the updated Instructions For Use (IFU) and instructing the customers to implement the revisions on the VITROS System as below:
- For VITROS ECi/ECiQ Systems: Scan the Magnetic Lot Card for Lot 1250 & above.
- For VITROS 3600, 5600 Systems: Install ADD DRV 5815 & above.
- Update the laboratory procedures and Laboratory Information System, as required.
The revision to the low end of the Measuring (Reportable) Range may affect the Laboratory Information System. Users are advised to consult with their Information Technology representative to determine the impact at their facility. IFU documents are also available on the Ortho-Clinical Diagnostics, Inc. (OCD) website. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Service |