Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27467 |
| Brand Name: | ORTHO VISION Analyzer and ORTHO VISION Max Analyzer |
| Model: | |
| Affected: | Software versions - APSW 5.13.0 and below |
| 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 the potential for false negative results when using the ORTHO VISION® Analyzer and/ or ORTHO VISION® Max Analyzer with some specific User Defined Protocol configurations. This issue only affects customers processing UDP tests with non-standard volumes. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 18/3/2021 |
