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

Ortho-Clinical Diagnostics, Inc., through its responsible unit Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., voluntarily initiated a recall of specific batches of its Homocysteine Assay Kits (Immunochemical Method). The recall was reported on April 7, 2013, to the National Medical Products Administration (NMPA) in China. The primary issue prompting this action was the confirmed discovery of negative deviations in the test results for the affected product, specifically batch number 1529-17-2636. These kits are designed for the quantitative determination of total homocysteine concentration in human serum and plasma using various VITROS automated analyzers. Under the NMPA's regulatory framework, while a global recall was initiated by Ortho-Clinical Diagnostics, Inc., the responsible unit in China confirmed that the particular problematic batch (1529-17-2636) had not been imported into China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. stated that no direct recall actions, further investigations, or implementation plans would be undertaken within China. However, the NMPA requested provincial and municipal drug administrations to enhance their supervision and management of such products to ensure public safety.