| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01251-1 |
| Product Name/Description |
VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems, Software Versions 3.1 & Below
System Product Codes: 6802783, 6802445, 6802413
ARTG Number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics investigation has determined that the software may not properly identify an expired calibration. Calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. If the anomaly occurs, a calibration may expire, but the system may not alert the operator and not flag results with a CE sample result code (i.e., Calibration Expired). The system may unexpectedly generate results even though it is configured to not report results when a calibration has expired The anomaly may potentially occur on any type of assay processed on the system
If an expired calibration occurs for an assay and is not detected by the operator, samples may be processed without a valid calibration. However, quality control fluids would be processed at the next routinely scheduled time period. If quality control results were acceptable, patient results obtained prior to that time would not have been adversely affected |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The resolution to this anomaly will be contained in the next version of software currently under development. Until the new software is installed on the affected VITROS System, users are advised to use the “All Assay Data” option instead of “Load New Lots" when installing Assay Data Diskettes (ADDs) on the system. If any of the calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. Users are also advised to discuss any concerns that may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |