DxC 500 AU Analyzer (Beckman Coulter) – result processing error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, 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.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: U.S. 2024090170 O.U.S. 2024060094 2024070114 2024090174 2024070118 Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers: U.S. 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 2024100209 2024100212 2024100215 2024100226 2024100228 2024100230 2025010248 O.U.S. 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 2024100222 2024100224 2025010246 2025010250
Beckman Coulter Inc. is recalling DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / due to The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed resul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Recommended Action
Per FDA guidance
On 03/17/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via email and postal mail to customers informing them that it was determined that the DxC 500 AU Clinical Chemistry Analyzer might assign a test result to an incorrect sample ID under the following workflow conditions. If after loading a barcoded sample tube (Sample A) analyzes are not completed or remain "in pending", and operator attempts to analyze a second sample tube (Sample B) in the same positions, the analyzer will complete and report the pending tests associated with Sample A. No results will be reported for Sample B. Customers are instructed to: . Beckman Coulter recommends reviewing your laboratory workflow, sample labeling/label integrity and positioning to determine impact and sharing this with your laboratory and/or Medical Director. . For current software version is V1.3, V1.4, V1.4.1, or V1.4.2 customers, contact your Beckman Coulter service representative at your earliest convenience to upgrade to software V1.4.3. To check the software version, follow the instructions in the Viewing Analyzer Version Information topic in the IFU. . The latest available system software (software V1.4.3) provides improved sample event information and real time reporting, identifying the specific location of the sample with tests that are not completed. This software will help in the management of this issue. . Follow the attached appendix A Job Aid, which will prevent the operator workflow described in the ISSUE section. The Job Aid will outline how to use the sample list to manage the samples which have not completed. . There is no requirement to reverify applications, for example, precision studies. . Beckman Coulter recommends posting this Recall Letter on or near the affected systems until the corrections have been made. any questions, contact Customer Support Center: . From website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026