Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36594 |
| Brand Name: | VITROS Chemistry Systems |
| Model: | VITROS XT 3400 Chemistry System, VITROS 4600 Chemistry System, VITROS 4600 Chemistry System - Refurbished, VITROS XT 7600 Integrated System, VITROS XT 7600 Integrated System - Certified |
| Affected: | Problem involving the VITROS System software and VITROS Chemistry Products Assay Data Disk (ADD), Data Release Versions (DRVs) 6359 (released on 01-Jan-2026) to 6365 (released on 13-Feb-2026). This problem affects all available software versions. |
| 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-Clinical Diagnostics Inc |
| Issue: | The manufacturer received customer complaints describing the inability to find VITROS™ Chemistry Products Calibrator Kit 32 in the Calibration Programming menu lot configuration while trying to calibrate VITROS™ Chemistry Products Na+, K+, Cl-, and ECO2 assays. During the ADD loading procedure, after selecting 'All Assay Data', the Calibrator Kit dialog prompts the operator to select either: 'Use current kit' – to allow continued use of the calibrator kit configured (Can be either VITROS™ Chemistry Products Calibrator Kit 2 or VITROS Calibrator Kit 32). 'Change kit' – to switch the VITROS System calibrator configuration from VITROS Calibrator Kit 2 to VITROS Calibrator Kit 32 (or vice versa). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/2/2026 |
