Reported Apr 9, 2025 · Ongoing
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- DxC 500 AU Clinical Chemistry Analyzer
- Catalog Numbers/UDI codesC63519 / 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
- Lot codes and dates
- Catalog NumberC63519
- UDI-DI code14987666545058
- Serial Numbers2024060094 2024070114 2024090174 2024090170 2024070118
- Catalog NumberC63520
- UDI-DI code14987666545065
- Serial Numbers
138 of 138 codes
202401002820240600852024070116202408015920230700092024070134202409017220240901992024010026202311002320240100242024010025202408015020240801522024080161202409016320240901652024090167202406007720240600822024100209202409019720230800112024010038202405006620240100352024050072202404005620240300492024020039202402004020240200462024070111202403005120240300522024010033202410021520241002032023090015202410022220241002242024060103202406010420241002072024030054202406010120240100292024100228202408014620240801382024080145202406010720240701132024090177202409017920230800122024050068202404006020240500742024020045
- Amount recalled
- 143 systems (U.S. 74 and O.U.S. 69)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Beckman Coulter Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.