The Recall Desk

FDA (Devices) recall action 76212

Siemens Healthcare Diagnostics, Inc recalled 4 products on 2017-03-15

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2017-03-15
Critical
0
Units
98,294

Why these products were recalled

DHEA-S causes falsely elevated progesterone results.

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.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2017-03-15

    Siemens IMMULITE Progesterone Test Kits Recalled for DHEA-S Interference

    Siemens is recalling IMMULITE Progesterone test kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Product Usage: For in vitro diagnostic use with the IMMULITE¿2000 Systems Analyzers- for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2017-03-15

    Siemens IMMULITE 2000 Progesterone Test Kits Recalled for False Results

    Siemens is recalling IMMULITE 2000 Progesterone kits because DHEA-S causes falsely elevated results, potentially affecting diagnosis.

    Product
    IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used…
    Category
    Distribution
    1 state