Recall Z-1517-2025 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 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
| Date | Apr 3, 2025 (initiated Feb 26, 2025) |
| Status | Open, Classified |
| 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 te |
| Root cause | Software design |
| Action | On 02/26/2025 and 3/10/2025, the firm send "URGENT MEDICAL DEVICE RECALL" Letters dated 2/20/2025 via email and postal mail to customer. The letter described the product, problem and actions to be taken. Customer are instruction to: . The calculated results can be recalculated manually offline by users based on the formula defined and rerun results from constituent tests. . Configure calculated tests within LIS/Middleware, if available. . Beckman Coulter recommends sharing the content of this letter with your laboratory and/or Medical Director. Any questions regarding this notice, contact o |
| Quantity | 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, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.