China NMPA Product Recall - Fully automated blood rheology analyzer

Chongqing Saihang Technology Development Co., Ltd. initiated a Class III voluntary recall of its Fully Automated Hemorheology Analyzer (model SH-210A, batch 2005B). This action, publicized by the National Medical Products Administration (NMPA) on April 12, 2021, followed the receipt of a test report on August 19, 2020. The primary violation identified was that the unit of seconds displayed in the product's print report preview did not conform to the IEC 60027 standard, contravening relevant regulatory provisions, including "Article 27." The recall impacted four units from batch 2005B, with one SH-210A unit specifically noted as sold in mainland China. Upon discovering the non-compliance, Chongqing Saihang Technology Development Co., Ltd. swiftly investigated the cause and implemented corrective measures. Users were immediately instructed to cease operation of the affected analyzers. The required corrective action involved company engineers deploying software patches, either on-site or remotely, to update the problematic products. This ensured that the preview reports now fully comply with the registered IEC 60027 standard. The company submitted its recall event report to the Provincial Drug Administration Department on August 26, 2020.