Recall Z-0083-2027

Recall number: Z-0083-2027
Event number: 99800
Firm: Beckman Coulter Inc.
Firm FEI: 2050012
Product code: JJE
Status: Open, Classified
Initiated: 2026-09-02
Posted: 2026-10-02
Root cause: Software design
510(k) numbers: K242190, K950915, K953239, K831518, K970227, K130915, K803267, K862818, K863840, K901346, K922220, K881498, K813102, K840883, K841916, K855196, K921661, K922072, K834521, K870833, K942443, K782014, K010500, K885226, K944028, K860748, K912844, K110035, K852262, K881495

Product#

DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252

Reason for Recall#

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and CDRHRecallGroup@fda.hhs.gov in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.