The Recall Desk

FDA (Devices) recall action 84823

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2020-03-11

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
2020-03-11
Critical
0
Units
2,149

Why these products were recalled

A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.

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)··2020-03-11

    Siemens Atellica IM Humidity Pack Recall Due to Software Error

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs because a software error causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-03-11

    Siemens Atellica IM Humidity Pack Software Error Recall

    Siemens Healthcare Diagnostics is recalling Atellica IM Humidity Packs due to a software error that causes the analyzer to incorrectly eject them as expired.

    Product
    Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric…
    Category
    Distribution
    0 states