Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0942-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.

Product Classification:

Class II

Date Initiated: October 8, 2013

Date Posted: February 19, 2014

Recall Number: Z-0942-2014

Event ID: 66467

Reason for Recall:

Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.

Status: Terminated

Product Quantity: 20 units

Code Information:

Custom v3.2.2 & Below Configuration Files

Distribution Pattern:

Worldwide Distribution - USA Nationwide in the states and countries of: AZ, FL, WV, TX, PA, DE, MI, OH, TN, IL, NC, Chile, India, Italy, Portugal, Spain, Sweden, UK

Voluntary or Mandated:

Voluntary: Firm initiated