| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01270-1 |
| Product Name/Description |
VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vitro diagnostic medical device (IVD).
Product Code: 1631779
ARTG Number for VITROS Chemistry Systems:180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
While performing an on-analyser dilution, some customers have reported an increase in EAE condition codes (Sample Metering Dilution Error). The data indicates that the rate of occurrence for EAE codes can vary between 2 and 25% for cups within the affected arrays. When an EAE condition code occurs, the processing for that sample is automatically cancelled by the system.
Ortho-Clinical Diagnostic's investigation into the increased rate of EAE condition codes determined that some of VITROS Mixing Cup Arrays may be out of specification. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho-Clinical Diagnostics is advising their customers to continue using the Mixing Cup arrays as there is currently no alternative available. It is recommended that laboratories perform manual dilutions for samples with low volume rather than using an onboard dilution. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |