The Recall Desk

FDA (Devices) recall action 62580

Sysmex America, Inc. recalled 3 products on 2012-11-14

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
2012-11-14
Critical
0
Units
1,931

Why these products were recalled

There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.

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)··2012-11-14

    Sysmex XE-2100 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 1,099 XE-2100 Automated Hematology Systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-11-14

    Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro…
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2012-11-14

    Sysmex XE-2100C Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.

    Product
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro…
    Category
    Distribution
    1 state