China NMPA Product Recall - Vancomycin Detection Kit (Homogeneous Enzyme Immunoassay)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Vancomycin Test Kits, as reported to the National Medical Products Administration (NMPA) on September 30, 2016. The recall stemmed from an inaccuracy in the product instructions regarding the detection method comparison for the Vancomycin Assay Kit (Homogeneous Enzyme Immunoassay). Specifically, the documentation incorrectly described the methodological comparison between results obtained on Roche's compatible fully automated biochemical analyzers (cobas c311/c501/c502 and Modular P) and the COBAS INTEGRA fully automated biochemical analysis system.

The company discovered that unmodified kits sold overseas, when used on the COBAS INTEGRA 800 system, produced results 20% higher than those obtained on the compatible systems. To address this, Roche Diagnostics decided to update the product instructions to correct the methodological comparison description. Notably, this recall did not involve product withdrawal or direct customer notification in China because the COBAS INTEGRA 800 system had been discontinued in the region, and compatible vancomycin kits for that specific system were never sold in the Chinese market. Therefore, the identified discrepancy posed no medical risk to Chinese users, and only two global complaints had been received, none from China.