CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
DxC 500 AU Clinical Chemistry Analyzer recalled by Beckman Coulter
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzer, distributed nationwide in the US. The recall was initiated on 17 Mar 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-1672-2025
- FDA event ID
- 96483
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2025
- FDA classified
- 25 Apr 2025
- Reported
- 7 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Mar 2025 | Recall initiated by company | |
| 25 Apr 2025 | Classified by FDA | +39 days |
| 7 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaColoradoGeorgiaIdahoIllinoisIndianaLouisianaMassachusettsMichiganMinnesotaMississippiMontanaNorth CarolinaNew MexicoNevadaNew YorkOklahomaOregonPennsylvania
Questions about this recall
Why was it recalled?
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Which lots are affected?
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
Where was it sold?
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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beckman Coulter
All 334| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | Access Total T4 Calibrator recalled by Beckman Coulter | Beckman Coulter | Other | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |