Reported May 7, 2025 · Ongoing

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065…

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?

  • DxC 500 AU Clinical Chemistry Analyzer
  • Catalog Numbers/UDI codesC63519 / 14987666545058 C63520 / 14987666545065
  • Software versionsV1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only
Lot codes and dates
  • Catalog NumberC63519
  • UDI-DI code14987666545058
  • Serial NumbersU.S. 2024090170 O.U.S. 2024060094 2024070114 2024090174 2024070118
  • Catalog NumberC63520
  • UDI-DI code14987666545065
  • Serial NumbersU.S.

    67 of 67 codes

    • 2023060005
    • 2023070009
    • 2023070010
    • 2023090015
    • 2023090016
    • 2023100019
    • 2023100020
    • 2023110022
    • 2024010033
    • 2024010035
    • 2024010036
    • 2024010037
    • 2024010038
    • 2024020041
    • 2024020042
    • 2024020043
    • 2024020045
    • 2024020046
    • 2024020047
    • 2024030049
    • 2024030051
    • 2024030052
    • 2024030053
    • 2024040056
    • 2024040059
    • 2024050064
    • 2024050070
    • 2024050072
    • 2024060075
    • 2024060088
    • 2024060096
    • 2024060101
    • 2024060103
    • 2024060104
    • 2024060106
    • 2024070109
    • 2024070110
    • 2024070111
    • 2024070116
    • 2024070128
    • 2024070129
    • 2024070130
    • 2024070131
    • 2024070132
    • 2024080138
    • 2024080139
    • 2024080142
    • 2024080145
    • 2024080157
    • 2024080159
    • 2024090177
    • 2024090179
    • 2024090183
    • 2024090190
    • 2024090192
    • 2024090194
    • 2024090195
    • 2024090197
    • 2024100205
    • 2024100207
    O.U.S.

    64 of 64 codes

    • 2023080012
    • 2023110023
    • 2024010024
    • 2024010025
    • 2024010027
    • 2024010028
    • 2024010029
    • 2024010030
    • 2024010031
    • 2024010032
    • 2024010034
    • 2024030055
    • 2024040060
    • 2024040062
    • 2024040063
    • 2024050066
    • 2024050068
    • 2024050074
    • 2024060077
    • 2024060082
    • 2024060085
    • 2024060099
    • 2024060102
    • 2024060107
    • 2024070108
    • 2024070113
    • 2024070115
    • 2024070119
    • 2024070120
    • 2024070121
    • 2024070123
    • 2024070124
    • 2024070125
    • 2024070126
    • 2024070127
    • 2024070134
    • 2024070136
    • 2024080141
    • 2024080144
    • 2024080146
    • 2024080148
    • 2024080149
    • 2024080150
    • 2024080152
    • 2024080153
    • 2024080155
    • 2024080161
    • 2024090163
    • 2024090165
    • 2024090167
    • 2024090172
    • 2024090176
    • 2024090181
    • 2024090185
    • 2024090188
    • 2024090199
    • 2024100201
    • 2024100214
    • 2024100217
    • 2024100219
Amount recalled
136 systems (U.S. 68 and O.U.S. 68)

Where it was sold

Why it was recalled

The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

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

Data as of Sep 19, 5:37 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.