The Recall Desk

FDA (Devices) recall action 80954

Siemens Healthcare Diagnostics, Inc recalled 5 products on 2018-10-24

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-10-24
Critical
0
Units
2,417

Why these products were recalled

A potential bias was identified with certain kits compared to the internal standards.

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.

1–5 of 5

  • ModerateFDA (Devices)··2018-10-24

    Siemens Atellica IM CKMB Master Curve Material Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling Atellica IM CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
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    Distribution
    0 states
  • ModerateFDA (Devices)··2018-10-24

    Siemens Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias

    Siemens Healthcare Diagnostics is recalling 1,870 ADVIA Centaur CKMB Calibrator kits due to a potential bias compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-10-24

    Siemens ADVIA Centaur CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 69 kits of ADVIA Centaur CKMB Calibrator 2-pack Japan due to a potential bias identified compared to internal standards.

    Product
    ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
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    Distribution
    0 states
  • HighFDA (Devices)··2018-10-24

    Siemens Atellica IM CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 97 kits of Atellica IM CKMB Calibrator due to a potential bias compared to internal standards.

    Product
    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-10-24

    Siemens ADVIA Centaur CKMB Master Curve Material Recalled for Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CKMB Master Curve Material due to a potential bias identified when compared to internal standards.

    Product
    ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Distribution
    0 states