The Recall Desk

FDA (Devices) recall action 66055

Siemens Healthcare Diagnostics recalled 2 products on 2014-02-05

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
2014-02-05
Critical
0
Units
6,896

Why these products were recalled

Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.

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)··2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products…
    Category
    Distribution
    0 states