China NMPA Product Recall - Hematoxylin staining solution; Hematoxylin II staining solution

On November 25, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Hematoxylin and Hematoxylin II Staining Solutions (Registration Certificate Nos.: 20150248; 20150245). This action followed internal stability monitoring by Roche Diagnostics headquarters, which identified an issue where the hematoxylin staining solution resulted in excessively deep restaining. This deficiency indicated that the affected products could not maintain their intended 24-month shelf life. As a corrective measure, and while the root cause is being thoroughly investigated, the shelf life for the affected product batches has been temporarily reduced from 24 months to 12 months. The company is actively conducting further investigations to understand the underlying issues and restore the original 24-month shelf life and product stability. The National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration oversee this recall. Roche Diagnostics Products (Shanghai) Co., Ltd. has confirmed that this issue is not expected to cause serious adverse health effects. Detailed information on affected models and batches is available in the "Medical Device Recall Report Form."