Vitros Chemistry System And Vitros Immunodiagnostic System
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry System and VITROS Immunodiagnostic System. [Device]. Affected: VITROS™ XT 3400 chemistry, VITROS™ 3600 Immunnodiagnostic, VITROS™ 3600 Immunodiagnostic , VITROS™ 4600 chemistry,VITROS™ 5600 Integrated, VITROS™ XT 7600 Integrated
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-03
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/f3c99dc7-7796-444c-ad5b-48d2c934751b