China NMPA Product Recall - Automatic dehydrator

On August 6, 2015, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its Automatic Tissue Dehydrator, model ASP6025, in China, under the oversight of the National Medical Products Administration (NMPA). The recall stems from an identified issue where, during the liquid filling process in the "3 Sample Blues" mode, the device could occasionally display an incorrect "empty bottle status." This malfunction, occurring when the liquid level surpasses sensor 2 but not sensor 3, compromises tissue dehydration quality. Such processing deficiencies could necessitate repeated biopsies for patients to obtain viable tissue samples, posing a significant concern for patient care and diagnostic accuracy.

In response, Leica Microsystems (Shanghai) Trading Co., Ltd. has implemented corrective measures. The primary required action involves instructing all Chinese users to discontinue the use of the problematic "3 sample blue (5L)" mode immediately. Instead, users are advised to exclusively employ the "2 sample blue (3.8L)" mode, which has been deemed safe and effective. This proactive step aims to mitigate the risk of poor tissue processing and ensure the reliability of diagnostic procedures. A total of 37 affected units were sold in China, and detailed information about these products is available in the "Medical Device Recall Event Report Form." This action underscores the company's commitment to product safety and regulatory compliance.