The Recall Desk

FDA (Devices) recall action 76339

Radiometer America Inc recalled 2 products on 2017-03-22

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
2017-03-22
Critical
0
Units
27,210

Why these products were recalled

Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

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)··2017-03-22

    Radiometer ABL90 Flex Analyzer Recalled for Sample Type Labeling Change

    Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'

    Product
    ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
    Category
    Distribution
    0 states