Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28501 |
| Brand Name: | Freelite Kappa/Lambda |
| Model: | |
| Affected: | Optilite Freelite® Kappa Free Kit (LK016.OPT) - lot 470792, Optilite Freelite Kappa Free Kit (x10) (LK016.10.OPT) - lot 470794, Optilite Freelite Mx™ Kappa Free Kit (LK016.M.OPT) - lot 473522 |
| Software version: | |
| Recalling Organisation: | The Binding Site Limited Grant Thornton New Zealand Ltd L4, 154 Fanshawe Street Auckland 1010 |
| Contact Information: | |
| Manufacturer: | The Binding Site Group Ltd |
| Issue: | The manufacturer has identified that the kits are likely to exhibit AC flags on calibrator 7. An AC flag occurs when the reaction kinetics exceed the Optilite threshold limits for the prozone check. When this occurs on a calibrator the flag is shown in the 'errors' field within the F4>3 calibration results screen of the Optilite software. |
| Recall action type: | Alert |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/10/2021 |
