China NMPA Product Recall - fully automated fluorescence PCR analyzer Cobas Z480

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its cobas Z 480 Automated Fluorescent PCR Analyzer, as announced by the National Medical Products Administration (NMPA) on February 11, 2021. This measure was prompted by 15 complaints received globally, including one in China, concerning false positive or invalid results when using the cobas 4800 IVD test. Following internal investigations by Roche Diagnostics headquarters, it was determined that 10 of these complaints were directly attributable to contaminated lens assemblies within the cobas Z 480 analyzer. The identified issue specifically affects the full-process and PCR process testing functions, with User-Defined Software (UDF) testing remaining unaffected. Operating under the NMPA's regulatory framework, Roche Molecular Systems is undertaking this recall to address the quality concerns. The required action involves retrieving affected units from the market. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form," underscoring the company's commitment to product reliability and diagnostic accuracy.