The Recall Desk

FDA (Devices) recall action 67210

Siemens Healthcare Diagnostics recalled 2 products on 2014-05-07

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
2014-05-07
Critical
0
Units
24,442

Why these products were recalled

Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

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)··2014-05-07

    Siemens IMMULITE Total IgE Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE Total IgE assays due to a confirmed 23% positive bias against the WHO 2nd IRP 75/502.

    Product
    IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers - for the quantitative measurement of
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-05-07

    Siemens Recalls IMMULITE 2000 Total IgE Assays Due to Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 2000 Total IgE assays because they show a 23% positive bias against the WHO standard.

    Product
    IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diagnostics Products Ltd. For in vitro diagnostic use with the IMMULITE, IMMULITE 1000, and IMMULITE 2000/ IMMULITE 2000 XPi Systems Analyzers
    Category
    Distribution
    0 states