Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24650 |
| Brand Name: | ARCHITECT BNP calibrators and Controls |
| Model: | |
| Affected: | Multiple 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 |
| Issue: | The manufacturer has identified an issue with the ARCHITECT BNP Calibrator and Controls. The impacted lots demonstrate a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing. The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human B-type natriuretic peptide (BNP) in human EDTA plasma. The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 31/5/2019 |
