The Recall Desk

FDA (Devices) recall action 81237

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2018-11-21

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
2018-11-21
Critical
0
Units
22,352

Why these products were recalled

There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.

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.

1–2 of 2

  • ModerateFDA (Devices)··2018-11-21

    Siemens Lipase Reagent Cartridge Recall for Lot Variability

    Siemens Healthcare is recalling specific lots of Dimension Lipase Flex Reagent Cartridges due to lot-to-lot variability affecting quality control and patient results.

    Product
    Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-11-21

    Siemens Dimension Vista Lipase Reagent Cartridge Recalled for Variability

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Lipase Flex Reagent Cartridges due to lot-to-lot variability in quality control and patient results.

    Product
    Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension Vista System.
    Category
    Distribution
    0 states