| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01001-1 |
| Product Name/Description |
VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0
VITROS MicroSlide Calibrator Kit Numbers: 1 - 10 (inc.) & 25
ARTG Number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
An unexpected assay calibration may occur when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits for assay targets that are unassigned. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A correction for this issue will be included in the next version of the software. Ortho-Clinical Diagnostics is requesting their customers to not use the calibrator barcode labels for VITROS Calibrator Kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on the VITROS System. This action has been closed-out on 25/08/2016. |
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services |