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DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C635...

FDA Device Recall #Z-1517-2025 — Class II — February 26, 2025

Recall Summary

Recall Number Z-1517-2025
Classification Class II — Moderate risk
Date Initiated February 26, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Beckman Coulter Inc.
Location Brea, CA
Product Type Devices
Quantity 143 systems (U.S. 74 and O.U.S. 69)

Product Description

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 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

Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.

Distribution Pattern

Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, Canada, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Republic of Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain and Switzerland

Lot / Code Information

Catalog Number: C63519 UDI-DI code: 14987666545058 Serial Numbers: 2024060094 2024070114 2024090174 2024090170 2024070118 Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers: 2024010028 2024060085 2024070116 2024080159 2023070009 2024070134 2024090172 2024090199 2024010026 2023110023 2024010024 2024010025 2024080150 2024080152 2024080161 2024090163 2024090165 2024090167 2024060077 2024060082 2024100209 2024090197 2023080011 2024010038 2024050066 2024010035 2024050072 2024040056 2024030049 2024020039 2024020040 2024020046 2024070111 2024030051 2024030052 2024010033 2024100215 2024100203 2023090015 2024100222 2024100224 2024060103 2024060104 2024100207 2024030054 2024060101 2024010029 2024100228 2024080146 2024080138 2024080145 2024060107 2024070113 2024090177 2024090179 2023080012 2024050068 2024040060 2024050074 2024020045 2024070128 2024070119 2024070115 2024020042 2024070120 2024070121 2024070123 2024070124 2024070125 2024070126 2024040062 2024010027 2024080148 2024010032 2024090181 2024010031 2024100226 2024020043 2024060099 2024010030 2024090176 2024090190 2024080141 2024040063 2024020047 2024060096 2024040059 2024060088 2024060075 2024060106 2024100230 2025010246 2023100019 2024070109 2024080139 2024080142 2024070108 2024030053 2024090185 2024080149 2024070136 2024090188 2024010034 2024070127 2023070010 2024070129 2024070130 2024080157 2024100205 2025010248 2024020041 2024100217 2024100219 2024030055 2024090183 2023060005 2024010036 2024010037 2024070132 2024070131 2023100020 2024090192 2024090194 2024080153 2024080155 2024060102 2024100214 2025010250 2024050064 2024050070 2024100212 2024090195 2023090016 2023100018 2023110022 2024070110 2024100201 2024080144

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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.

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