China NMPA Product Recall - Fully automated urine analyzer; Automated urine analyzer

On April 9, 2020, Beckman Coulter Trading (China) Co., Ltd. announced a voluntary Class III recall concerning its Fully Automated Urine Analyzer (Automatic Urine Analyzer). This significant action, overseen by the National Medical Products Administration (NMPA), was prompted by the discovery of a manufacturing defect. Specifically, a faulty SATA adapter cable was identified within the PC6 model computers supplied with these analyzers. This particular cable is crucial for providing external power to the CD drive integrated into the computers, which are connected to iQ200 and/or iChem VELOCITY instruments.

The affected instruments, comprising various models and specifications, were originally installed by Beckman Coulter between July 2012 and December 2014. The primary issue stems from the cable's inability to consistently deliver power, potentially impacting the functionality of the computer's CD drive and, by extension, the overall performance of the automated urine analyzer. To address this non-conformity, Beckman Coulter Trading (China) Co., Ltd. is systematically recalling the identified products. The company has provided a "Medical Device Recall Event Report Form" for comprehensive details on the specific batches and models involved in this corrective measure, ensuring user safety and product reliability under the regulatory guidance of the NMPA.