Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18822 |
| Brand Name: | Roche Reflotron Uric Acid Test |
| Model: | Material Number: 10745103202 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Roche Diagnostics has reduced the hematocrit value to a maximum of 48% for the Reflotron Uric Acid test when measuring patient samples from whole blood. The internal investigation detected deviations in Uric Acid results on Reflotron system, which can be above the internal specification of 5%, if the hematocrit values exceed 48%. This may lead to erroneously low Uric Acid results in blood samples with hematocrit values higher than 48%. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/7/2015 |
