Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19811 |
| Brand Name: | Roche Elecsys Estradiol 11 and 111 Assays |
| Model: | 03000079190 and 06656021190 |
| Affected: | all lot numbers |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | If the estradiol status of postmenopausal women under treatment with fulvestrant is tested with Elecsys Estradiol II or Elecsys Estradiol III assays, an interference leading to falsely increased results of Estradiol due to the drug may occur. Subsequently the incorrect level of estradiol may lead to misinterpretations of the hormone status and the use of fulvestrant may be altered. In addition the efficiency of anti-estrogen treatment might be underestimated. A medical risk for postmenopausal women under fulvestrant treatment cannot be excluded. |
| Recall action type: | Correction |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/3/2016 |
