BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. recalls DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.

Recall date

January 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1233-2025

FDA classification

Class II

Brand / firm

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.