China NMPA Product Recall - Flow Cytometer

The National Medical Products Administration (NMPA) issued an updated recall notice on February 11, 2019, concerning Beckman Coulter, Inc.'s FC 500 and XL/XL-MCL Flow Cytometers. The manufacturer, through its agent Beckman Coulter Trading (China) Co., Ltd., initiated this voluntary recall due to a critical malfunction. The primary issue is potential signal loss or drift caused by a faulty amplification plate within the devices, which could compromise patient analysis results. Although no patient injuries have been reported, continued use of the affected cytometers poses a risk of serious, life-threatening health consequences, including misdiagnosis or improper treatment of blood disorders.

Initially a Class III recall issued on May 23, 2018, the severity level was elevated to Class I in January 2019, signifying a higher risk. A total of 923 affected units were sold in China. Under the NMPA's regulatory framework, Beckman Coulter has been notifying customers since January 2018, providing instructions for visual data review. For the FC500 model, updated system software with a diagnostic tool has been released to identify and facilitate the replacement of defective amplifier boards. Additionally, service support for the EPICS XL model ceased on December 31, 2018, with the company assisting customers in transitioning to newer flow cytometer models.