Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28500 |
| Brand Name: | Freelite Kappa/Lambda |
| Model: | |
| Affected: | LK018.S - lot 472776, LK018.10S - lot 472664, LK018.L.S - lot 435251 |
| 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: | It has been identified that calibration curves produced using LK018.S lot 472776 have a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 (110.45mg/L) and calibrator point 6 (173.76mg/L), which can be exacerbated when calibrator 6 activity reaches the optical ceiling of the SPA+ analyser. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2021 |
