Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36836 |
| Brand Name: | VITROS™ Chemistry Products SALI Slides |
| Model: | Catalog number - 131 4343 (10758750008773) |
| Affected: | Affected GENs - 04 and above |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/o Quigg Partners Level 7, 36 Brandon Street Wellington 6011 |
| Contact Information: | 0800 402 899 |
| Manufacturer: | Ortho Diagnostic Systems Inc |
| Issue: | The manufacturer has identified an issue involving Condition Code TH4-63J, which may lead to calibration failures and/or an inability to generate patient results using VITROS™ Chemistry Products SALI Slides lots from Generations (GENs) 04 and above, on VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/5/2026 |
