| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00017-1 |
| Product Name/Description |
VITROS Chemistry System. An in vitro diagnostic medical device (IVD)
VITROS 250 Chemistry System - Product Codes: 8132086, 6801759
VITROS 350 Chemistry System - Product Code: 6802153
VITROS 5,1 FS Chemistry System - Product Codes: 6801375, 6801890
VITROS 4600 Chemistry System - Product Code: 6802445
VITROS 5600 Integrated System - Product Code: 6802413
ARTG Number 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics, Inc. (Ortho) is initiating this recall action due to the need to clarify operator actions following U90-382 or 6LU condition codes generated by the VITROS Chemistry systems.
U90-382 or 6LU condition codes are associated with wash errors that may occur when using VITROS Chemistry Products for immuno-rate assays (i.e., VITROS CRBM, CRP, DGXN, and PHYT Slides).
If a U90-382 or 6LU condition code (i.e., associated with a wash error) occurs, the condition code text located on the VITROS System and other user documentation indicates to dilute the sample. However, dilution may not be the appropriate action for all scenarios.
For therapeutic monitoring, falsely low result due to dilution could potentially cause unnecessary drug dose increase, leading to side effects |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users to follow the instructions given in the customer letter as a temporary measure when results are flagged with a Wash Error (WE) code. A software upgrade will be installed on all affected systems in the near future as a permanent fix.
This action has been closed out on the 12/10/2018. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |