The Recall Desk

FDA (Devices) recall action 73263

Siemens Healthcare Diagnostics, Inc recalled 3 products on 2016-03-16

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-03-16
Critical
0
Units
519

Why these products were recalled

ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay

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.

1–3 of 3

  • ModerateFDA (Devices)··2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 because they show bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 due to bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E packs due to bias in the testosterone assay. The recall covers 519 packs distributed worldwide.

    Product
    Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone.…
    Category
    Distribution
    0 states