Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36519 |
| Brand Name: | VITROS Chemistry System and VITROS Immunodiagnostic System |
| Model: | |
| Affected: | VITROS™ XT 3400 chemistry, VITROS™ 3600 Immunnodiagnostic, VITROS™ 3600 Immunodiagnostic , VITROS™ 4600 chemistry,VITROS™ 5600 Integrated, VITROS™ XT 7600 Integrated |
| 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 Biotech Products LP |
| Issue: | The manufacturer received a customer complaint regarding an erroneous result generated due to the use of an unintended reagent cartridge for a different assay. The investigation identified that the issue resulted from a combination of a software anomaly and user error. During a Manual Load procedure, a non-empty reagent cartridge was incorrectly presented to the operator after the LOAD DOOR was opened. The cartridge, which should have been removed, remained in the slot and was incorrectly identified by the VITROS System as the intended manually loaded reagent. As a result, the unintended reagent cartridge was used to process the sample and generate an erroneous result. The investigation confirmed that this issue can only occur if the reagent cartridge presented at the load door is not removed and the intended reagent is not loaded during the Manual Load procedure for VITROS MicroSlide, MicroTip, and/or MicroWell reagents. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 3/2/2026 |
