The Recall Desk

FDA (Devices) recall action 64610

Siemens Healthcare Diagnostics, Inc recalled 4 products on 2013-04-24

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2013-04-24
Critical
0
Units
8,376

Why these products were recalled

Negative bias in patient samples for Vitamin D

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.

1–4 of 4

  • ModerateFDA (Devices)··2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
    Category
    Distribution
    0 states