DxC 500 AU Clinical Chemistry Analyzer
Medical device recall Z-1672-2025. Published in FDA’s Enforcement Report on May 7, 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 May 7, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 26 states named
- 136 systems (U.S. 68 and O.U.S. 68) 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?
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
136 systems (U.S. 68 and O.U.S. 68), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,653 characters
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
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 - U.S. Nationwide distribution including in the states of AL, CA, CO, GA, ID, IL, IN, LA, MA, MI,MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI. The countries of Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Georgia, Germany, Ghana, India, Italy, Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Puerto Rico, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain, Switzerland, and Tunisia.
The states and territories these words name
26 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Georgia
- Idaho
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- Montana
- North Carolina
- New Mexico
- Nevada
- New York
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Washington
- Wisconsin
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 Mar 17, 2025.
- FDA classified it on Apr 25, 2025.
- FDA’s Enforcement Report published it on May 7, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, CA.
- 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
-
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.