Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21394 |
| Brand Name: | ARCHITECT Free T4 Reagent |
| Model: | |
| Affected: | List number 7K65-29, 100 Test Kit Multiple lots, 7K65-34, 2000 Test Kit Multiple lots, 7K65-39, 500 Test Kits Muliple lots |
| Software version: | |
| Recalling Organisation: | Abbott Australasia Pty Ltd (NZ) Abbott Laboratories NZ 4 Pacific Rise, Mt Wellington Auckland 1060 |
| Contact Information: | 61 2 93849717 |
| Manufacturer: | Abbott Bioresearch Centre |
| Issue: | The manufacturer has determined that the measuring interval is 0.40 ng/dL to 5.00 ng/dL. the estimated frequency of falsely elevated or decreased fT4 results is occasional (0.04%). Only results well above the medical decision point are impacted. Changes to results in this range of values are unlikely to change clinical interpretation and therefore, patient management is not impacted. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Wholesale |
| Date Commenced: | 1/5/2017 |
