The Recall Desk

FDA (Devices) recall action 83349

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2019-08-28

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
2019-08-28
Critical
0
Units
—

Why these products were recalled

There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

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

1–2 of 2

  • HighFDA (Devices)··2019-08-28

    Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

    Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

    Product
    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-08-28

    Siemens IMMULITE 1000 Progesterone Test Recall for Low Results

    Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.

    Product
    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
    Category
    Distribution
    0 states