The Recall Desk

FDA (Devices) recall action 62897

Siemens Healthcare Diagnostics, Inc recalled 2 products on 2012-09-26

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
2012-09-26
Critical
0
Units
15,445

Why these products were recalled

ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

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.

1–2 of 2

  • LowFDA (Devices)··2012-09-26

    Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-09-26

    Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in v
    Category
    Distribution
    0 states