Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27109 |
| Brand Name: | ID-DiaCell |
| Model: | |
| Affected: | All lots currently in date |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Medical Diagnostics GmbH |
| Issue: | The manufacturer has identifeid 2 issues when using ID-DiaCall: 1) NonSpecific reactions: - Primarily observed on QC samples but also with some patient samples and eluates. Doubtful reactions or in some cases false positive reactions may occur randomly between batches and within a same batch. This can appear with both manual and all automated methods. 2) Insufficient Homogenization of the RBCs within the vials when stored on-board either on the IH-500 or on the IH-1000 and when the remaining volume reaches 2ml or lower. This lack of homogenization can lead to a dispense of low-concentrated red blood cell reagent into the wells of the ID-cards. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/12/2020 |
