The Recall Desk

FDA (Devices) recall action 86970

Siemens Healthcare Diagnostics, Inc. recalled 3 products on 2021-01-20

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-01-20
Critical
0
Units
5,088

Why these products were recalled

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient 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.

1–3 of 3

  • HighFDA (Devices)··2021-01-20

    Siemens Atellica CH 930 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica CH 930 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and in
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    Siemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.23.2 or lower because the software may report discrepant patient results.

    Product
    Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and i
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    Siemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzers with software version 1.23.2 or lower because multiple software issues may lead to the reporting of discrepant patient results.

    Product
    Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and i
    Category
    Distribution
    0 states