HIGH

Beckman Coulter Recalls DxC 500i Clinical Analyzers Over Software Errors

Beckman Coulter recalled 160 DxC 500i Clinical Analyzer modules on September 19, 2025. A software anomaly may cause incorrect manual dilution factors, leading to false patient results. Healthcare providers must stop using the devices immediately to avoid erroneous diagnoses.

Quick Facts at a Glance

Recall Date
September 19, 2025
Hazard Level
HIGH
Brand
Beckman Coulter
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes the DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, and Access 2 Module. The affected part numbers are C63522, C63521, and C13252. These devices were distributed worldwide.

The Hazard

The software anomaly may prevent correct application of user-specified manual dilution factors. This issue can lead to false low or high patient results, risking erroneous diagnoses.

What to Do

Stop using the affected devices immediately. Follow the manufacturer's recall instructions. Contact Beckman Coulter, Inc. or your healthcare provider for further instructions.

Contact Information

For assistance, contact Beckman Coulter at the recall hotline or visit their website. Detailed recall instructions are available through their customer service.

Key Facts

  • Recall date: September 19, 2025
  • 160 units affected
  • Risk of erroneous patient diagnoses
  • Worldwide distribution
  • Contact Beckman Coulter for guidance

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeClinical Analyzer
Sold At
Multiple Retailers

Product Details

Model Numbers
C63522 UDI-DI: 14987666545089
C63521 UDI-DI: 14987666545072
C13252 UDI-DI: 15099590742331
Serial Numbers: 750198 750058 750222 750128 750138 750069 750050 750055 750179 750180 750181 750109 750168 750104 750211 750073 750210 750209 750178 750151 750153 750152 750155 750185 750187 750188 750195 750196 750201 750197 750199 750204 750202 750205 750083 750079 750186 750052 750230 750228 750140 750077 750135 750130 750167 750095 750105 750175 750132 750082 750113 750221 750219 750100 750099 750174 750053 750246 750134 750217 750216 750236 750233 750143 750081 750085 750071 750208 750207 750076 750131 750148 750223 750137 750116 750166 750241 750240 750183 750193 750200 750070 750087 750239 750107 750093 750124 750215 750141 750145 750144 750117 750108 750184 750173 750224 750218 750123 750129 750054 750206 750146 750101 750112 750194 750115 750157 750159 750160 750162 750125 750103 750229 750226 750234 750133 750048 750163 750182 750192 750189 750158 750250 750214 750110 750247 750154 750080 750251 750232 750231 750255 750238 750253 750074 750047 750102 750147 750142 750092 750094 750164 750165 750225 750212 750064 750065 750177 750086 750088 750042 750043 750254 750044 750056 750169 750045 750057 750127 750156
Affected States
ALL
Report Date
October 29, 2025
Recall Status
ACTIVE

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