Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19021 |
| Brand Name: | Roche IgE II assay |
| Model: | 04827031190 |
| Affected: | All lots in the market |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Internal investigations have found there is no direct binding competition between Xolair® and the Anti-IgE antibodies of the IgE II assay. However, Xolair® forms soluble complexes with IgE antibodies, and this leads to reduced recovery of the IgE II assay. This effect can only be seen when creating serial dilutions of a sample and checking the linearity of these different dilutions. It will not necessarily be detected by performing a single dilution of the sample. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/8/2015 |
