China NMPA Product Recall - Fully automatic slide pushing and staining system

The National Medical Products Administration (NMPA) issued a notification (Index No.: JGXX-2017-10681) on July 21, 2017, concerning a voluntary Class III product recall. The recall was initiated by Beckman Coulter, Inc., regarding their fully automated slide dispensing and staining system (Registration No.: 20160725), distributed in China by Beckman Coulter Trading (China) Co., Ltd. The central issue prompting this recall is the identified slow dripping of staining reagents, such as formaldehyde, ethanol, or buffer solutions, from specific connectors within the automated system. This defect could potentially compromise the efficacy and accuracy of the staining process, impacting diagnostic results, and may present a containment concern due to reagent leakage. Operating under the regulatory framework of the NMPA, Beckman Coulter, Inc. is undertaking a voluntary recall as the required action to mitigate these product deficiencies. Comprehensive details concerning the affected product models, specifications, and batches are provided in the "Medical Device Recall Event Report Form" attached to the official communication. This measure underscores the commitment to upholding product quality and patient safety standards within the medical device sector as regulated by the NMPA.