Recall Z-1672-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 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 acces
| Date | Apr 25, 2025 (initiated Mar 17, 2025) |
| Status | Open, Classified |
| Reason | The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 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 Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Georgia, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Jul 20, 2023 |