Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26418 |
| Brand Name: | ORTHO VISION |
| Model: | |
| Affected: | ORTHO VISION and ORTHO VISION Max BioVue Analyzers When Testing High Titer Samples |
| 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 (UK) |
| Issue: | The manufacturer has received complaints of discordant positive reactions for healthy donor and patient samples when using ORTHO Sera anti-D (IAT) (Product No. 6904493) with AHG Anti-IgG Ortho BioVue® System cassettes (Product No. 707400/707450) and IAT XM tests with Anti-Human Globulin Anti-IgG, -C3d; polyspecific Ortho BioVue System® cassettes (Product No. 707300/707350). |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/8/2020 |
