The Recall Desk

FDA (Devices) recall action 78838

Abbott Laboratories, Inc recalled 3 products on 2018-03-14

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
2018-03-14
Critical
0
Units
—

Why these products were recalled

There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument.

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2018-03-14

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories,
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-03-14

    Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

    Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

    Product
    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratorie
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2018-03-14

    Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

    Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.

    Product
    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15
    Category
    Distribution
    1 state