Vitros Chemistry Products Mg Slides

Recalling firm
Ortho-Clinical Diagnostics
Product
VITROS Chemistry Products Mg Slides. [Device]. Model: Catalog number - 825 5093 - 60-Slide Cartridges 192 1204 - 18-Slide Cartridges. Affected: All in-date and future lots
Reason
The manufacturer became aware of the problem through customer complaints. The VITROS Mg Slides Instructions For Use (IFU) states an On-analyzer stability of = 2 weeks, when the VITROS System is turned on; however, investigation has determined that VITROS Mg Slides results may experience a negative drift outside acceptable limits (greater than 2 within-lab Standard Deviations (WLSD)) sooner than 2 weeks, when cartridges are stored on the VITROS System. This problem affects all current in-date and future lots of VITROS Mg Slides.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-03-02
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/807d79de-ea20-41e8-850b-587071cb5936