Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15787 |
| Brand Name: | The Binding Site Group Human IgM kit for use on SPA Plus |
| Model: | NK012.S and NK012.10S |
| Affected: | all lot numbers |
| Software version: | |
| Recalling Organisation: | In Vitro Technologies 26-30 Vestey Drive Mount Wellington Panmure Auckland |
| Contact Information: | 0800 468 487 |
| Manufacturer: | The Binding Site Group Ltd |
| Issue: | Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/L. The antigen excess capacity of this product has been reviewed and has been confirmed as correct. Investigations have suggested that the tested sample contained predominantly monoclonal IgM and the manufacturer believes that this particular type of IgM reacted aberrantly with the antibody and subsequently yielded the spurious result. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/12/2013 |
