The Recall Desk

FDA (Devices) recall action 83655

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2019-10-30

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
2019-10-30
Critical
0
Units
—

Why these products were recalled

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

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

1–2 of 2

  • HighFDA (Devices)··2019-10-30

    Siemens Atellica IM 1300 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-10-30

    Siemens Atellica IM 1600 Analyzer Software Recall for Reagent Lot Scanning Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers running software versions V1.19.0 and V1.19.2 due to issues scanning new reagent lot test definitions.

    Product
    Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
    Category
    Distribution
    0 states