CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
DxC 500i Clinical Analyzer Modules recalled by Beckman Coulter
Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules, distributed nationwide in the US. The recall was initiated on 19 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0215-2026
- FDA event ID
- 97638
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Sep 2025
- FDA classified
- 21 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Sep 2025 | Recall initiated by company | |
| 21 Oct 2025 | Classified by FDA | +32 days |
| 29 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is DxC 500i Clinical Analyzer Modules recalled?
Yes. Beckman Coulter recalled DxC 500i Clinical Analyzer Modules on 19 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0215-2026.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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