The Recall Desk

FDA (Devices) recall action 82329

Beckman Coulter Inc. recalled 3 products on 2019-05-29

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
2019-05-29
Critical
0
Units
7,814

Why these products were recalled

Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.

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

  • SevereFDA (Devices)··2019-05-29

    Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors

    Beckman Coulter is recalling 2,059 UniCel DxH 600 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2019-05-29

    Beckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling UniCel DxH 800 analyzers because sporadic platelet results may be erroneously elevated without system flags, potentially leaving thrombocytopenia unrecognized.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2019-05-29

    Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors

    Beckman Coulter is recalling 341 UniCel DxH 900 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.

    Product
    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s…
    Category
    Distribution
    1 state