DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Softw

FDA device recall Z-1672-2025 · posted 2025-04-25 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.

Action taken

On 03/17/2025, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via email and postal mail to customers informing them that it was determined that the DxC 500 AU Clinical Chemistry Analyzer might assign a test result to an incorrect sample ID under the following workflow conditions. If after loading a barcoded sample tube (Sample A) analyzes are not completed or remain "in pending", and operator attempts to analyze a second sample tube (Sample B) in the same positions, the analyzer will complete and report the pending tests associated with Sample A. No results will be reported for Sample B. Customers are instructed to: . Beckman Coulter recommends reviewing your laboratory workflow, sample labeling/label integrity and positioning to determine impact and sharing this with your laboratory and/or Medical Director. . For current software version is V1.3, V1.4, V1.4.1, or V1.4.2 customers, contact your Beckman Coulter service representative at your earliest convenience to upgrade to software V1.4.3. To check the software version, follow the instructions in the Viewing Analyzer Version Information topic in the IFU. . The latest available system software (software V1.4.3) provides improved sample event information and real time reporting, identifying the specific location of the sample with tests that are not completed. This software will help in the management of this issue. . Follow the attached appendix A Job Aid, which will prevent the operator workflow described in the ISSUE section. The Job Aid will outline how to use the sample list to manage the samples which have not completed. . There is no requirement to reverify applications, for example, precision studies. . Beckman Coulter recommends posting this Recall Letter on or near the affected systems until the corrections have been made. any questions, contact Customer Support Center: . From website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJE

Quantity affected

136 systems (U.S. 68 and O.U.S. 68)

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, CA, CO, GA, ID, IL, IN, LA, MA, MI,MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI. The countries of Australi

Date initiated

2025-03-17

Date posted

2025-04-25

Location

Brea, CA

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