The Recall Desk

FDA (Devices) recall action 79556

Mindray DS USA, Inc. dba Mindray North America recalled 2 products on 2018-04-18

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
2018-04-18
Critical
0
Units
5,334

Why these products were recalled

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.

Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.

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

1–2 of 2

  • HighFDA (Devices)··2018-04-18

    Mindray Hematology Diluent M-30D Recalled for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-30D diluent used with BC-3200 and BC-3600 analyzers because they may cause the system to produce an elevated platelet background count.

    Product
    Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for u
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-04-18

    Mindray Hematology Diluent Recall for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-53D and M-30D hematology diluents because they may cause the analyzer to produce an elevated platelet background count.

    Product
    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
    Category
    Distribution
    6 states