The Recall Desk

FDA (Devices) recall action 79699

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2018-05-16

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
2018-05-16
Critical
0
Units
—

Why these products were recalled

Incorrect calibrator level listed in qualitative calibration steps

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

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2018-05-16

    Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents

    Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
    Category
    Distribution
    9 states
  • LowFDA (Devices)··2018-05-16

    Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.

    Product
    Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
    Category
    Distribution
    9 states