China NMPA Product Recall - Megaw staining solution and Giemsa staining solution

Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary recall of specific batches of its Megau and Giemsa staining solutions, as reported to the National Medical Products Administration (NMPA) on February 29, 2012, and publicly announced on March 14, 2012. The primary issue identified was that if these staining solutions were left in a staining tank for more than two hours, they could lead to poor staining effects, making cell morphology unrecognizable during diagnostic procedures. This quality concern impacted specific models and batch numbers (e.g., Item Numbers 7547200 and 7547201, Batch Numbers 0624776, 0626171, 0627615). The recall focused on overseas markets, including France, Israel, and Spain, with Beckman Coulter confirming that the affected products were not sold or imported into the Chinese market. Despite the absence of direct impact on China, the NMPA requested that provincial Food and Drug Administrations strengthen their supervision and management of similar products within their regions to ensure continued product quality and patient safety.