FDA-Device2025-03-05Class II
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Hazard
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.
Sold states
US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR. OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of Korea
Affected count
56
Manufactured in
No. 11 Shengpu Street Zhensheng Road, Pingjiang, Suzhou, N/A, China
Products
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2025Don't want to check this manually?
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