Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20912 |
| Brand Name: | Abbott ARCHITECT Active-B12 Reagent kits |
| Model: | |
| Affected: | Lot number - 10533UP00, 10534UP00 |
| 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 Diagnostics Division |
| Issue: | Manufacturer has identified a lot specific stability issue with both reagent lots 10533UP00 and 10534UP00. As the reagent ages, Relative Light Unit (RLU) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. Controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/12/2016 |
