Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16251 |
| Brand Name: | Abbott ARCHITECT Intact PTH Calibrators, Controls, and Reagents |
| Model: | Product Codes: 8K25-20, 8K25-25 |
| Affected: | Specific 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 GmbH & Co. KG |
| Issue: | Falsely elevated Intact PTH results may be generated. Results generated with affected lots may demonstrate a positive shift relative to that generated with previous reagent and/or calibrator lots. Abbott ARCHITECT Intact PTH Controls do not detect the shift. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/2/2014 |
