Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25985 |
| Brand Name: | ARCHITECT iGentamicin Reagent Kit |
| Model: | |
| Affected: | All Lots |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics Division Ground Floor, Building D 4 Pacific Rise Mt Wellington AUCKLAND 1640 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Diagnostics Division Ireland |
| Issue: | The manufacturer identified that samples tested for ARCHITECT STAT High Sensitive Troponin-I and STAT High Sensitivity Troponin-I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted. Preliminary results from Abbott internal analysis of field data from these two assays show false elevation of patient results with a frequency of 0.002%. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/5/2020 |
