Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22898 |
| Brand Name: | Roche Elecsys Vitamin D Assay (100 tests) |
| Model: | 07464215190 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Brand Name: | Roche Elecsys Vitamin D Assay (300 tests) |
| Model: | 07028148190 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The manufacturer has been informed of a number of reports of performance issues during the implementation of the Elecsys Vitamin D total II assay on modular analytics E170, cobas e601 and Cobas e 602 systems, as well as rare cases on cobas e 411 and cobas e 801. The issue manifests as: the first result is elevated, either above the upper end of the measuring range (>250 nmol/L) or within the measuring range; and repeats are significantly lower. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/4/2018 |
