Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29818 |
| Brand Name: | Automated immuClone Anti-K (Kell) IgM |
| Model: | 0066088 |
| Affected: | 922040, 922041, 922042, 922043 |
| Software version: | |
| Recalling Organisation: | Paragon Care Group New Zealand Limited 69 Elizabeth Knox Place Glen Innes AUCKLAND |
| Contact Information: | 0508 654 258 |
| Manufacturer: | Immucor Medizinische Diagnostik GmbH |
| Issue: | During the transfer of the mentioned product to the Regulation on IVD Medical Devices (EU) 2017/746, our supplier listed in the product labeling of Automated immuClone Anti-K (Kell) IgM informed Immucor Medizinische Diagnostik GmbH, that the clone K1.1.21.HM.EF is indeed clone MS-56. The clone identified in the instructions for use, K1.1.21.HM.EF, was based on the documentation provided by the supplier. The manufacturer had no knowledge that actual clone was different and of the incorrect branding. As the performance level established for the product is not affected, the probability for occurrence for patient harm remains low. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/8/2022 |
