Ortho-Clinical Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-1004-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 29, 2014

Date Posted: January 28, 2015

Recall Number: Z-1004-2015

Event ID: 69727

Reason for Recall:

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

Status: Terminated

Product Quantity: 12 units

Code Information:

System Product Code: 1) 6802445, 2) 6802413

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated