The Recall Desk

FDA (Devices) recall action 75798

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2016-12-28

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
2016-12-28
Critical
0
Units
—

Why these products were recalled

Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.

Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.

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

1–2 of 2

  • HighFDA (Devices)··2016-12-28

    Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-12-28

    Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.

    Product
    IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Product
    Category
    Distribution
    0 states