Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18871 |
| Brand Name: | Abbott Architect B12 Reagent Kit |
| Model: | 7K61-35, and 7K61-25, |
| Affected: | 53921UI00, 50956UI00; and 50957UI00 |
| 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: | During the manufacture of the ARCHITECT B12 reagent kits (List 7K61) listed above, an incorrect IFU (Instructions for use) commodity number G3-0354/R04 may have been inserted into the reagent kits. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/7/2015 |
