Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20924 |
| Brand Name: | Ortho Reagent Red Blood cell Products |
| Model: | 719102, 6902317, 6902315, 6902316, 719402, 719522, 719201, 6902096, 719502, 719810, 6902318, 719210, 6902319, 6901865, 719510, 707910, 7192042, 719602, 719100, 7192041, 6908163, 719610, 707950, 7191041, 719221, 719202, 707930 |
| Affected: | Multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/o Quigg Partners Level 7, 36 Brandon Street Wellington 6011 |
| Contact Information: | 0800 402 899 |
| Manufacturer: | |
| Issue: | Manufacturer has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in Ortho Reagent Red Blood Cell (RRBC) products as well as Quality Control products containing red blood cells. An extensive investigation identified microbial contamination as the root cause for the marked hemolysis. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/12/2016 |
