DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU…
Medical device recall Z-0215-2026. Published in FDA’s Enforcement Report on Oct 29, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 29, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 160 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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)
160 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,228 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 19, 2025.
- FDA classified it on Oct 21, 2025.
- FDA’s Enforcement Report published it on Oct 29, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter, Inc., of Chaska, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.