Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15059 |
| Brand Name: | Ortho Clinical Diagnostics BioVue System Cassettes |
| Model: | BioVue ABD confirmation Cassette, VioVue Rh/K Cassette, BioVue ABO-DD Grouping Cassette, BioVue ABO-Rh Grouping Cassette, BioVue Poly/Neutral Cassette |
| Affected: | Lots: 6904485 and 707135 |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics European Support Centre |
| Issue: | Ortho Clinical Diagnostics (OCD) has identified isolated occurrences of improperly positioned cassette labels for the products specified. The use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. There is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/8/2013 |
