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Open, Classified

DxI 9000 Access Immunoassay Analyzer C11137

FDA Recall Z-1996-2025 · Posted 2025-06-20

Recalling FirmBeckman Coulter, Inc.
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2025-05-07
Product Quantity67 US; 178 OUS

Reason for Recall

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.

Firm 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 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2022-11-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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