Reported Mar 5, 2025 · Ongoing
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
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 LABORATORY SYSTEMS (SUZHOU) CO., LTD. · No. 11 Shengpu Street Zhensheng Road · Suzhou, N/A · N/A
Is this the product you have?
- DxC 500 AU Clinical Chemistry Analyzer
- REF
C63519and C63520 with affected software
- Lot codes and dates
2 of 2 products · 56 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Serial Numbers C63519149876665450582024090170
C63520149876665450652024070116202307000920240100382024010035202405007220240400562024030049202402004620240701112024030051202403005220240100332023090015202406010320240601042024060101202408014520240200452024020042202402004320240200472024060096202404005920231000192024030053202307001020240701292024070130202402004120240901832024010036202401003720240701322024070131202310002020240500642024050070202309001620231100222024070110202406007520240601062023110023202401002420240100252024050066202401002920240601072023080012202404006020240500742024040062202401003120240300552024080144
- Amount recalled
- 56
Where it was sold
Why it was recalled
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
This product could cause temporary or reversible health problems — stop using it.
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