The Recall Desk

FDA (Devices) recall action 86972

Ortho-Clinical Diagnostics, Inc. recalled 2 products on 2021-01-13

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
2021-01-13
Critical
0
Units
80

Why these products were recalled

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-01-13

    Ortho-Clinical VITROS Automation Software Recall for Sample Labeling Errors

    Ortho-Clinical Diagnostics is recalling VITROS Automation Solutions software due to a defect that may cause samples to be mislabeled, potentially leading to incorrect patient results.

    Product
    VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
    Category
    Distribution
    9 states
  • SevereFDA (Devices)··2021-01-13

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.

    Product
    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: 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-se
    Category
    Distribution
    9 states