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RecallWatchMedical Device Safety
Class IIOngoingZ-1517-2025

Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer

Beckman Coulter Inc.Brea, CA, United StatesReported Apr 9, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeCatalog # Number
    145 affected lots
    20240600942024070114202409017420240901702024070118C63520149876665450652024010028
    +137 more20240600852024070116202408015920230700092024070134202409017220240901992024010026202311002320240100242024010025202408015020240801522024080161202409016320240901652024090167202406007720240600822024100209202409019720230800112024010038202405006620240100352024050072202404005620240300492024020039202402004020240200462024070111202403005120240300522024010033202410021520241002032023090015202410022220241002242024060103202406010420241002072024030054202406010120240100292024100228202408014620240801382024080145202406010720240701132024090177202409017920230800122024050068202404006020240500742024020045202407012820240701192024070115202402004220240701202024070121202407012320240701242024070125202407012620240400622024010027202408014820240100322024090181202401003120241002262024020043202406009920240100302024090176202409019020240801412024040063202402004720240600962024040059202406008820240600752024060106202410023020250102462023100019202407010920240801392024080142202407010820240300532024090185202408014920240701362024090188202401003420240701272023070010202407012920240701302024080157202410020520250102482024020041202410021720241002192024030055202409018320230600052024010036202401003720240701322024070131202310002020240901922024090194202408015320240801552024060102202410021420250102502024050064202405007020241002122024090195202309001620231000182023110022202407011020241002012024080144

What the firm is doing

On 02/26/2025 and 3/10/2025, the firm send "URGENT MEDICAL DEVICE RECALL" Letters dated 2/20/2025 via email and postal mail to customer. The letter described the product, problem and actions to be taken. Customer are instruction to: . The calculated results can be recalculated manually offline by users based on the formula defined and rerun results from constituent tests. . Configure calculated tests within LIS/Middleware, if available. . Beckman Coulter recommends sharing the content of this letter with your laboratory and/or Medical Director. Any questions regarding this notice, contact our Customer Support Center: . From our website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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