The Recall Desk

FDA (Devices) recall action 87870

Radiometer Medical ApS recalled 3 products on 2021-06-23

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
2021-06-23
Critical
0
Units
—

Why these products were recalled

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2021-06-23

    Medical Device Analyzer Spare Parts Recalled for Internal Clock Defect

    Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.

    Product
    E3800 PC Units (spare parts)
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2021-06-23

    Radiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction

    Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.

    Product
    Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2021-06-23

    Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Internal Clock Issue

    Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.

    Product
    Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
    Category
    Distribution
    46 states