Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29015 |
| Brand Name: | Alinity m STI Amp Kit |
| Model: | |
| Affected: | 517789, 518275, 519550, 519599, 520273, 520401 |
| Software version: | |
| Recalling Organisation: | Abbott Australasia Pty Ltd (NZ) Abbott Laboratories NZ 4 Pacific Rise, Mt Wellington Auckland 1060 |
| Contact Information: | 61 2 93849717 |
| Manufacturer: | Abbott Bioresearch Centre |
| Issue: | There is potential for incorrect results (false negative Neisseria gonorrhoeae) results in the following scenario: For customers that run the 09N17-091 kit with the unintended Alinity m STI Application Specification File (09N17-01B), any Neisseria gonorrhoeae (NG) results with a Cycle Number (CN) between 40.00 and 41.00 would be called Negative. Those results would be called Positive with the Alinity m STI Application Specification File (09N17-05A). Therefore, there is a potential risk for False Negative results for NG samples with a CN between 40.00 and 41.00. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/2/2022 |
