The Recall Desk

FDA (Devices) recall action 66774

Ortho-Clinical Diagnostics recalled 2 products on 2014-03-05

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
2014-03-05
Critical
0
Units
548,663

Why these products were recalled

Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

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

  • ModerateFDA (Devices)··2014-03-05

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.

    Product
    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System f
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2014-03-05

    Ortho VITROS Sodium Slides Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.

    Product
    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems a
    Category
    Distribution
    49 states