Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27056 |
| Brand Name: | EliA dsDNA Well |
| Model: | |
| Affected: | Kit lot number 0142 |
| Software version: | |
| Recalling Organisation: | Abacus dx New Zealand Unit B, 30 Vestey Drive Mt Wellington Auckland 1060 |
| Contact Information: | 0800222170 |
| Manufacturer: | Phadia AB |
| Issue: | The manufacturer has identified that the EliA dsDNA Well lot BFA3Y/ 0142 gives higher results, and in some cases the results may be up to 3 times higher than for other EliA dsDNA Well lots. Results >15 IU/ml to 45 IU/ ml may potentially be false positive. The investigation has concluded that there are no deviations for the EliA ANA Positive Control or other EliA dsDNA Well lots. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/12/2020 |
