Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26364 |
| Brand Name: | Elecsys Anti-TPO |
| Model: | |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Diagnostics |
| Issue: | The issue as described leads to a maximum recovery of 125.9 % for Anti-TPO at 29.5 IU/mL. The cutoff value for Anti-TPO is given at 34 IU/mL. Falsely elevated Anti-TPO results may lead to wrongly assumption of positive Anti-TPO status of a patient and to wrong assumption of Hashimoto's thyroiditis in patients as sublying cause of (subclinical) hypothyroidism and may affect further diagnostic steps. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/8/2020 |
