Beckman Coulter recalled 116 DxC 500i Clinical Analyzer modules on August 4, 2025, due to potential processing delays. The defect may impact the accuracy of test results when ordering certain tests simultaneously. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled modules include the DxC 500 AU Module w/ISE, REF: C63522, and DxC 500 AU Module, Without ISE, REF: C6352. The affected models were distributed internationally to various countries.
The defect may cause Clinical Chemistry test samples to remain marked as 'In Progress' without errors when ordered simultaneously with Immunoassay tests. This issue can lead to significant processing delays, impacting patient care.
There have been no reported injuries or deaths associated with this recall. The potential for processing delays raises concerns about timely diagnosis and treatment.
Patients and healthcare providers should stop using the affected devices immediately. Contact Beckman Coulter Inc. or your healthcare provider for further instructions and follow the recall notification method provided.
For assistance, call Beckman Coulter Inc. at 1-800-XXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0032-2026.
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