China NMPA Product Recall - Iron detection kit (colorimetric method)

On May 21, 2021, the National Medical Products Administration (NMPA) reported a voluntary Class II recall initiated by Roche Diagnostics Products (Shanghai) Co., Ltd. This action stems from an internal complaint investigation by Roche Diagnostics headquarters, which identified a systematic discrepancy in sample results for specific batches of its iron assay kit (colorimetric method), known as IRON2. The affected products include the cobas c 311/501/502 and COBAS INTEGRA 400 plus (cobas c pack) iron assay kits. This issue could lead to inaccurate iron level measurements, potentially impacting patient diagnostics. Importantly, other iron assay kits, specifically for cobas c 701/702, cobas c 303/503, and cobas c 111, are not implicated in this recall. Operating under the oversight of the NMPA, the company has taken proactive steps to address the identified product performance issue. The recall signifies the company's commitment to product quality and patient safety. Full details regarding the specific models, specifications, and affected batch numbers are provided in the accompanying "Medical Device Recall Event Report Form," which serves as the official record of the event and guides customers on the necessary actions to manage the recalled products.