China NMPA Product Recall - Hexamine silver staining solution; periodic acid-Schiff staining solution (PAS Staining Kit); Masson trichrome staining solution (Trichrome Staining Kit)

On January 3, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall for specific batches of its hexamine silver staining solution, periodic acid Schiff staining solution PAS Staining Kit, and Masson Trichrome Staining Kit. This action, reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, stemmed from a critical issue where the transportation temperature for certain imported products exceeded the required range. The temperature excursion during import transportation compromised the integrity of these medical device staining solutions, which are vital for diagnostic procedures. The recall specifically targets products identified by particular waybill numbers and associated with Registration Certificate Nos.: 20161977, 20160195, 20151709. Roche Diagnostics emphasized that only products under the specified waybills with these batch numbers are affected, reassuring that other batches and products are not impacted. The company provided a "Medical Device Recall Event Report Form" for detailed information regarding the affected product models, specifications, and batches. This proactive recall demonstrates the company's adherence to regulatory standards for product quality and safety, ensuring that potentially compromised diagnostic solutions are removed from the market.