DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C635...
FDA Device Recall #Z-1672-2025 — Class II — March 17, 2025
Recall Summary
| Recall Number | Z-1672-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 17, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Beckman Coulter Inc. |
| Location | Brea, CA |
| Product Type | Devices |
| Quantity | 136 systems (U.S. 68 and O.U.S. 68) |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
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
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.