The Recall Desk

FDA (Devices) recall action 78611

Beckman Coulter Inc. recalled 3 products on 2017-12-20

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
2017-12-20
Critical
0
Units
19

Why these products were recalled

The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

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.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2017-12-20

    Beckman Coulter UniCel DxH800 Automated Hematology Analyzer Recall

    Beckman Coulter is recalling 15 UniCel DxH800 automated hematology analyzers because the Single-Tube Station shield may interfere with sample aspiration.

    Product
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
    Category
    Distribution
    6 states