Company: Beckman Coulter Inc.
Date of Enforcement Report: 4/3/2025
Class II

PRODUCT

DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 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.

Recall Number:

Z-1517-2025

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter Inc.

VOLUME:

143 systems (U.S. 74 and O.U.S. 69)

DISTRIBUTION:

Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, Canada, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Republic of Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain and Switzerland.