Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22052 |
| Brand Name: | Reagent Fluorocell Plt |
| Model: | |
| Affected: | Lots 6051 – 6090. |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Sysmex Corporation |
| Issue: | some of the reagent Fluorocell Plt within the affected lots are susceptible to external environmental factors and tend to decrease their dye concentration over time. This deterioration resulted in incorrect Plt-F results with a high discrepancy between the Plt-I value and a falsely low Plt F value. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/10/2017 |
