Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20995 |
| Brand Name: | Ortho Clinical Diagnostics Vitros Chemistry Product Na Slides |
| Model: | |
| Affected: | Generation (GEN) 1 through 6, 30 through 40, 44 through 49 |
| 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 has identified the potential for biased results to be generated over the 10 day on-analyzer limit when using VITROS Na+ Slide cartridges warmed between 1 1/2 to 8 hours then placed on the analyzer. The manufacturer has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit. Follow up and resolution November 2017 The manufacturer is introducing VITROS Electrolyte Reference Fluid (ERF) 300 and VITROS Electrolyte Reference Fluid (ERF) 800 with a revised formulation that: 1. Restores the Na+ cartridge warm-up protocol to 90 minutes when taken from the refrigerator (120 minutes from the freezer) as defined in the VITROS Na+ Slides Instructions for Use. 2. Reformulated ERF helps to reduce sources of variability (e.g., calibration variability) observed when using VITROS Na+ Slides. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/11/2017 |
