Company: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
Date of Enforcement Report: 2/25/2025
Class II
PRODUCT
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Recall Number:
Z-1233-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
VOLUME OF PRODUCT IN COMMERCE:
56 units
DISTRIBUTION:
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
