Recall Z-0968-2014— Ortho-Clinical Diagnostics

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-10-10, terminated 2018-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable, intermediate container used in making automatic (auto)-dilutions on the VITROS 250/350 Chemistry Systems. The VITROS 250 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Microslides. The VITROS 350 Chemistry System is intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides.. Reason: Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing Cup Arrays utilized on VITROS 250 and VITROS 350 Chemistry Systems. Increase in Software error due to affected Mixing Cup Arrays..

Recalling firm

Ortho-Clinical Diagnostics

Classification

Class II

Status

Terminated

Initiated

2013-10-10

Terminated

2018-05-18

Firm location

Rochester, NY, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.