Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27608 |
| Brand Name: | ORTHO VISION |
| Model: | ORTHO VISION® Analyzer for ORTHO® BioVue Cassettes and ORTHO VISION® Max Analyzer for ORTHO® BioVue Cassettes |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/o Quigg Partners Level 7, 36 Brandon Street Wellington 6011 |
| Contact Information: | 0800 402 899 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Issue: | The manufacturer has identified a potential for intermittent false positive results being generated on ORTHO VISION® or ORTHO VISION® Max analyzers when processing ORTHO Sera anti-D (IAT) and Indirect Antiglobulin Test (IAT) crossmatch (XM) tests after pipetting plasma or serum samples with high titer ABO antibodies. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/4/2021 |
