China NMPA Product Recall - Fully automated slide preparation and staining system / blood analyzer

Beckman Coulter Trading (China) Co., Ltd. initiated a Class II voluntary recall on October 25, 2016, affecting its Fully Automated Slide Pushing and Staining System and Blood Analyzer products. This action was prompted by overseas reports of dye solution (methanol) combustion occurring within the slide dyeing machine module at user sites. The incident, potentially linked to its connected blood analyzer, was attributed to a significant increase in the frequency of automatic charging of the cresol pool. The root cause remains under investigation.

Under the oversight of the National Medical Products Administration (NMPA), Beckman Coulter implemented several corrective measures. The company promptly informed affected customers about the potential risks and provided relevant information. A critical upgrade has been released for the fully automated slide preparation and staining system, with existing users undergoing these updates. Additionally, the issue has been addressed in the blood analyzer with the release of version 3.0.2.0. Beckman Coulter Trading (China) Co., Ltd. is committed to reporting monthly progress updates to the Shanghai Drug Administration to ensure effective resolution.