Reported Nov 6, 2013 · Terminated

COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology…

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?

  • COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Lot codes and dates
  • Part Numbers6605362 for the LH 750 and 723585 for the LH 780
  • Serial Numbers

    1,695 of 1,695 codes

    • AJ08102
    • AK49053
    • AM09075
    • AM10078
    • AG05059
    • AK41634
    • AT02015
    • AL41189
    • AJ06078
    • AF22202
    • AK34502
    • AL02001
    • AS49367
    • AM10085
    • AJ10154
    • AM40321
    • AS41335
    • AK32475
    • AS30241
    • AU28106
    • AK36538
    • AL18073
    • AL18077
    • AL37150
    • AH15237
    • AL09039
    • AL09042
    • AK02032
    • AJ31547
    • AJ24410
    • AM24242
    • AN13074
    • AN13075
    • AN13078
    • AT18112
    • AT18115
    • AG45676
    • AK46036
    • AG39545
    • AJ24402
    • AJ43796
    • AK49046
    • AM05019
    • AH21364
    • AH21367
    • AH21368
    • AH21369
    • AH21375
    • AH23391
    • AT26118
    • AN11064
    • AM02006
    • AE44164
    • AJ05072
    • AJ04046
    • AJ05065
    • AJ05073
    • AN19134
    • AG17221
    • AH43790
Amount recalled
1,697 units

Where it was sold

  • Nationwide

Why it was recalled

The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 9, 2014 · Data as of Sep 19, 6:07 PM UTC

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