Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21471 |
| Brand Name: | Calprotectin Card (20 test kit with stool vials & positive control) |
| Model: | |
| Affected: | Lots CP-052 |
| Software version: | |
| Recalling Organisation: | Abacus ALS Limited 55b Richard Pearse Drive Airport Oaks Auckland 2022 |
| Contact Information: | 0800 222 170 |
| Manufacturer: | Abacus Diagnostics |
| Issue: | Lots CP-052 and CP-047 were evaluated using a strip reader and standard preparations of Calprotectin ranging from 125 ng/mL to 4000 ng/mL. Comparative results using the strip reader and visual examination showed the intensity of the reactions were stronger on lot CP-047 than lot CP-052. When the concentration of calprotectin in a stool sample is near to the test detection limit (500 ng/mL), some samples could be interpreted as negative, depending on the lot and the visual interpretation. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/5/2017 |
