Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18611 |
| Brand Name: | Vitros Performance verifier 1 |
| Model: | 8067324 |
| Affected: | Lot Numbers: A3823 C4084 Q2961 T3161 V3297 and X3569 |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | |
| Issue: | The manufacturer has observed a positive bias with the first slide used from a cartridge that has been stored in the slide supply. The bias has been observed with multiple fluids across multiple GENs and coating of slides and across the 5,1.FS, 4600 amd 5600 analyzer platforms. The frist slide bias may occur when a cartridge is loaded on an analyzer and is not used for approximately 5-14 days. OCD has revised the Range of Means for Vitros Performance Verifier1 for unconjugated biirubin (Bu) only. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/6/2015 |
