The Recall Desk

FDA (Devices) recall action 82980

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2019-07-10

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
2019-07-10
Critical
0
Units
4,285

Why these products were recalled

A steady upward trend in blank (u) absorbance was observed

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

  • ModerateFDA (Devices)··2019-07-10

    Siemens ADVIA Chemistry Creatine Kinase Reagent Recalled for Absorbance Trend

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.

    Product
    ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithi
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-07-10

    Siemens Recalls Atellica CH Creatine Kinase Reagent Due to Absorbance Trend

    Siemens Healthcare Diagnostics is recalling 899 units of Atellica CH Creatine Kinase (CK_L) Reagent because a steady upward trend in blank absorbance was observed.

    Product
    Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium h
    Category
    Distribution
    0 states