Reported Sep 14, 2016 · Terminated

UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800…

Beckman Coulter Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
Lot codes and dates
  • Serial No.

    3,114 of 3,114 codes

    • AZ28848
    • AZ20791
    • AZ20789
    • AZ25359
    • AZ25362
    • AM51052
    • AZ23820
    • AZ28405
    • AZ28406
    • AZ02009
    • AW23066
    • AW16273
    • AW02003
    • AV52153
    • AU44687
    • AU44682
    • AV09188
    • AY50973
    • AZ25374
    • AV09197
    • AZ03660
    • AZ06661
    • AW23164
    • AY10661
    • AT48671
    • AY17706
    • AV11202
    • AS24187
    • AU42604
    • AU42605
    • AU47775
    • AU47783
    • AU45705
    • AW02013
    • AT09135
    • AT18249
    • AT18247
    • AW05068
    • AW02059
    • AW12090
    • AU19248
    • AU19249
    • AU19248
    • AW02020
    • AV35049
    • AV38713
    • AU36511
    • AU36519
    • AY17711
    • AY04037
    • AY01034
    • AY17198
    • AV28561
    • AZ28855
    • AY42926
    • AY42921
    • AU44671
    • AY24762
    • AY24768
    • AU36524
Amount recalled
5,282 units total (2,877 units in US)

Where it was sold

Why it was recalled

There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 29, 2017 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.