Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0941-2014)

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 Select v5.0 with autoverification enabled 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-0941-2014

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: 8 units

Code Information:

Autoverification and Custom Rules for enGen Laboratory Automation Systems using enGenTM Select v5.0

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