Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26193 |
| Brand Name: | EliA ANA Positive Control 250 |
| Model: | |
| Affected: | PU83103301 MR13/C9RDF is the only lot affected in NZ |
| Software version: | |
| Recalling Organisation: | Abacus ALS 12 Mowbray Terrace East Brisbane QLD 4169 Australia |
| Contact Information: | |
| Manufacturer: | Phadia AB |
| Issue: | The investigation shows that many of the results are found in the lower half of the expected range for EliA dsDNA Well of the affected lots. Consequently, more results may be found below the limit stated in the certificates. This does not have an effect on the correctness of the test results generated for patient samples since the EliA dsDNA wells are not affected. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/6/2020 |
