China NMPA Product Recall - Fully automated blood rheology analyzer

Chongqing Saihang Technology Development Co., Ltd. initiated a voluntary Class III recall for its Fully Automated Hemorheology Analyzer (Model SH-210A, Registration No.: "渝械注准2017240"), as publicized by the National Medical Products Administration (NMPA) on September 25, 2020. This action followed a test report received on August 19, 2020, from the Chongqing Medical Device Testing Center. The core issue identified was that the unit of seconds displayed in the product's printed report preview did not comply with the IEC 60027 standards, which subsequently impacted its registration status and required regulatory intervention. The affected batch, 2005B, involved four units. In response, Chongqing Saihang Technology Development Co., Ltd. promptly investigated the non-compliance and mandated that users immediately cease operating the identified products. The required corrective action involved company engineers applying software patches through on-site or remote visits to rectify the non-conforming preview report, ensuring full compliance with the registered IEC 60027 standard. This recall highlights the NMPA's framework for ensuring medical device safety and adherence to specified technical documentation standards.