The Recall Desk

FDA (Devices) recall action 66467

Ortho-Clinical Diagnostics recalled 2 products on 2014-02-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-02-19
Critical
0
Units
28

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Software Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.

    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 Pr
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-19

    Ortho-Clinical Diagnostics Recalls enGen Track System Due to Autoverification Anomaly

    Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 due to an anomaly affecting the autoverification feature and custom rules.

    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 V
    Category
    Distribution
    0 states