Ortho-Clinical Diagnostics recalls VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family m…

Recall date

September 29, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1004-2015

FDA classification

Class III

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and Spain.

Why it was recalled

Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System 1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes