The Recall Desk

FDA (Devices) recall action 65224

Siemens Healthcare Diagnostics, Inc recalled 4 products on 2013-06-12

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
2013-06-12
Critical
0
Units
—

Why these products were recalled

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

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

1–4 of 4

  • ModerateFDA (Devices)··2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Distribution
    0 states