Recall Z-1996-2025 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137
| Date | Jun 20, 2025 (initiated May 7, 2025) |
| Status | Open, Classified |
| Reason | Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS. |
| Root cause | Software design |
| Action | The firm began notifying customers the week of May 7, 2025 via Urgent Medical Device Recall letters. Only analyzers running software version 1.20 are affected. Customers were provided with instructions on what to do if they observe a calibration that remains in the "In Progress" or "Presented" state. Beckman Coulter will release a service modification to change a configuration setting to prevent this issue. Your service representative will schedule the service modification installation when it is available. In the meantime, it is recommended that customers share the content of this letter wit |
| Quantity | 67 US; 178 OUS |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Beckman Coulter, Inc., Nov 10, 2022 |