Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24239 |
| Brand Name: | Elecsys® FT4 III assays. |
| Model: | |
| Affected: | Elecsys FT4 III (100 tests) - MODULAR ANALYTICS E170, cobas e 411, cobas e 601, cobas e 602, Elecsys FT4 III E2G (300 tests) - cobas e 801 |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | Roche Diagnostics GmbH |
| Issue: | The manufacturer has identified a reduced biotin interference threshold for the recently launched ElecsysR FT4 III assays. The described threshold in the method sheet is 409 nmol/L or 100 ng/mL of biotin in a sample. However, for the following reagent lots the threshold is 81.8 nmol/L or 20 ng/mL. In patient samples with biotin concentrations of 266 nmol/L or 65 ng/mL, FT4 recovery could lead to a difference of >20%. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/2/2019 |
