The Recall Desk

FDA (Devices) recall action 64304

Veridex, LLC recalled 2 products on 2013-08-21

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
2013-08-21
Critical
0
Units
—

Why these products were recalled

Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of the issue and provide instructions to help prevent an occurrence on your CELLTRACKS AUTOPREP System and CELLTRACKS ANALYZER II.

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

1–2 of 2

  • HighFDA (Devices)··2013-08-21

    Veridex CellTracks Analyzer II Recalled for Patient Data Association Error

    Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-08-21

    Veridex CellTracks AutoPrep System Recalled for Patient Data Mismatch

    Veridex is recalling CellTracks AutoPrep System software due to a reported error where patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in…
    Category
    Distribution
    0 states