The Recall Desk

FDA (Devices) recall action 76124

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2017-02-08

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
2017-02-08
Critical
0
Units
—

Why these products were recalled

Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.

Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.

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

1–2 of 2

  • HighFDA (Devices)··2017-02-08

    Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results

    Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-02-08

    Siemens Recalls IMMULITE PSA Kits Due to Negative Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Distribution
    0 states