Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26694 |
| Brand Name: | ORTHO BioVue® System Cassettes |
| Model: | |
| Affected: | Multiple product codes |
| 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 Diagnostic Systems Inc |
| Issue: | ORTHO AutoVue Systems has been revised to clarify the Description of Issue to include: Additional testing on the ORTHO VISION Platform indicates that while agglutinates may be present in the supernatant, interpretation by the Camera Imaging System (CIMS) interprets the reaction grade as 4+ so the ORTHO VISION systems are not affected by this issue. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/12/2020 |
