Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18173 |
| Brand Name: | Abbott Architect Anti-HBc II Reagent Kit |
| Model: | List Numbers: 8L44-25, 8L44-30, 8L44-35 |
| Affected: | Lot Numbers: 42072LI00, 42072LI01, 42253LI00, 42253LI01, 42255LI00, 42255LI01, 42256LI00 |
| 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 GmbH & Co. KG |
| Issue: | The ARCHITECT Anti-HBc II assay shows lower calibrator, control and sample RLU values, potentially leading to reduced specificity and increased false reactive results. Internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. Cosnequently there is the potential for false reactive patient results. Note that assay sensitivity is not impacted. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/2/2015 |
