China NMPA Product Recall - Blood glucose test strips (glucose dehydrogenase method)

Roche Diagnostics Products (Shanghai) Co., Ltd. has initiated a voluntary Class II recall of its blood glucose test strips (glucose dehydrogenase method), as announced by the National Medical Products Administration (NMPA) on July 30, 2021. The recall stems from the rare occurrence of accidental openings in the test strip cartridges during transportation, coupled with a lack of comprehensive guidance within the existing product instructions on how to manage such incidents. This issue affects specific models and batches of the test strips, identified by Registration Certificate Nos. 20162402313 and 20162402312. The company's proactive measure underscores its commitment to product quality and patient safety, ensuring that users have appropriate instructions for handling their medical devices. Further details regarding the affected products are available in the accompanying "Medical Device Recall Event Report Form" referenced by NMPA Index No. JGXX-2021-10414. This action ensures compliance with regulatory expectations for medical device manufacturers in China.