Vitros Chemistry Systems
- Recalling firm
- Ortho-Clinical Diagnostics
- Product
- VITROS Chemistry Systems. [Device]. Model: VITROS XT 3400 Chemistry System, VITROS 4600 Chemistry System, VITROS 4600 Chemistry System - Refurbished, VITROS XT 7600 Integrated System, VITROS XT 7600 Integrated System - Certified. Affected: Problem involving the VITROS System software and VITROS Chemistry Products Assay Data Disk (ADD), Data Release Versions (DRVs) 6359 (released on 01-Jan-2026) to 6365 (released on 13-Feb-2026). This problem affects all available software versions.
- Reason
- The manufacturer received customer complaints describing the inability to find VITROS™ Chemistry Products Calibrator Kit 32 in the Calibration Programming menu lot configuration while trying to calibrate VITROS™ Chemistry Products Na+, K+, Cl-, and ECO2 assays., During the ADD loading procedure, after selecting 'All Assay Data', the Calibrator Kit dialog prompts the operator to select either:, 'Use current kit' – to allow continued use of the calibrator kit configured (Can be either VITROS™ Chemistry Products Calibrator Kit 2 or VITROS Calibrator Kit 32)., 'Change kit' – to switch the...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-26
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/c5f01e53-82ea-4678-b12a-7b41df6509e3