Ortho-Clinical Diagnostics: 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.

Agency Publication Date: February 9, 2014

Affected Products

Product: 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

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

Product: 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.

Custom v3.2.2 & Below Configuration Files

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66467

Status: Resolved

Manufacturer: Ortho-Clinical Diagnostics

Manufactured In: United States

Units Affected: 2 products (8 units; 20 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

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

Custom v3.2.2 & Below Configuration Files