| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00765-1 |
| Product Name/Description |
VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below)
VITROS 3600 Immunodiagnostic System
System Product Code: 6802783
VITROS 4600 Chemistry System
System Product Code: 6802445
VITROS 5600 Integrated System
System Product Code: 6802413 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigation confirmed that under specific circumstances, patient demographics may be incorrectly associated with a sample ID number. This issue may occur when Condition Code PY1-075 is generated for a sample ID and the operator does not follow the instructions provided below in the Condition Review in V-DOCs. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to move the sample to different cup and position if a PY1-075 condition code occurs on your VITROS® 3600, 4600 or 5600 System during sample processing. A correction will be included in the next scheduled software update. This action has been closed-out on 06/07/2016. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |