The Recall Desk

FDA (Devices) recall action 70918

Ortho-Clinical Diagnostics recalled 2 products on 2015-06-17

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
2015-06-17
Critical
0
Units
—

Why these products were recalled

Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.

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

1–2 of 2

  • ModerateFDA (Devices)··2015-06-17

    Ortho-Clinical Diagnostics Recalls VITROS Urine Assay Data Disks

    Ortho-Clinical Diagnostics is recalling VITROS Urine Assay Data Disks because a software error may allow samples requiring acidified pretreatment to be metered from the same container as those requiring no pretreatment.

    Product
    Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidi
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-06-17

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.

    Product
    VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment
    Category
    Distribution
    0 states