China NMPA Product Recall - Vancomycin Assay Kit (Immunochemical Method)

The National Medical Products Administration (NMPA) issued a notice (Index No. JGXX-2012-10070) on June 20, 2012, concerning a voluntary product recall by Ortho-Clinical Diagnostics, Inc. The recall involves certain models of their vancomycin assay kits (immunoassay) due to potential calibration deviations. The core issue arises when different generations of these kits are simultaneously loaded onto specific VITROS® 5,1 FS or VITROS® 5600 automated analyzers running older software versions. Under these conditions, the system might unexpectedly switch to and utilize a previous batch of reagents for quality control, potentially leading to inaccurate calibration if a specific condition code ('PV2-097') is overlooked by the operator. Ortho-Clinical Diagnostics, Inc., facilitated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., confirmed that this global recall does not impact the Chinese market. All affected kits were reported to be expired, meaning no products within China required active recall measures. As a result, China will not issue a separate recall implementation report. The NMPA instructed provincial and municipal food and drug administrations to reinforce their supervision of similar medical products.