Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19634 |
| Brand Name: | Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems |
| Model: | 6802153 |
| Affected: | 10758750002054 |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Issue: | Manufacturer has initiated a recall due to the need to clarify operator actions folloing U90-382 or 6LU cnditions codes generated by the system. If a U90-382 or 6LU condition code (i.e associated with a wash error) occurs, the condition code text located on the VITRO System and other user documentation indicates to dilute the sample. However dilution may not be the appropriate action for all scenarios. This notification provides additional information to a Product Correction Notification that Ortho Clinical Diagnostics (Ortho) issued in December 2015 (Medsafe Ref. 19634) regarding the clarification of operator actions for wash errors. Since that time, Ortho has been monitoring the occurrence of U90-382 or 6LU condition codes associated with wash errors. We observed an increase in wash errors for VITROS Chemistry Products PHYT Slides. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/11/2016 |
