The Recall Desk

FDA (Devices) recall action 77515

CSL Behring GmbH recalled 2 products on 2017-12-06

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
2017-12-06
Critical
0
Units
—

Why these products were recalled

Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein Controls SL for Ceruloplasmin are similarly biased. --- The affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards. Note: N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended. --- Siemens investigation indicated that N Protein Standard SL and correspondin…

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

1–2 of 2

  • ModerateFDA (Devices)··2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Distribution
    0 states