DxI 9000 Access Immunoassay Analyzer C11137
Recall
- Recall Number
- Z-1996-2025
- Event Number
- 96876
- Firm
- Beckman Coulter, Inc.
- FEI Number
- 2122870
- Product Code
- JJE
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- May 7, 2025
- Posted
- June 20, 2025
- Address
- 1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037
Description
DxI 9000 Access Immunoassay Analyzer C11137
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.
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 with your laboratory and/or medical director to determine if a review of previous patient test results is necessary. Beckman Coulter recommends posting the recall letter on or near the affected systems until corrections have been made.
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, Italy, Kazakhstan, Korea, Republic of, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.
67 US; 178 OUS