Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22798 |
| Brand Name: | Immunohaematology (ivd) |
| Model: | |
| Affected: | LISS/Coombs, Coombs Anti-IgG, DiaScreen , LISS/Coombs + Enzyme Test, DiaClon Type + Screen |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Laboratories Inc |
| Issue: | The manufacturer has identified an increased level of Antibody of Undetermined Specificity (AUS) when using some reagents of the ID-System intended for irregular antibody screening and identification: ID-Cards for Indirect Antiglobulin Testing (IAT) associated to Reagent Red Blood Cells. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/4/2018 |
