China NMPA Product Recall - Troponin-I Assay Kit (Chemiluminescent Microparticle Immunoassay)

Abbott Laboratories, through its unit Abbott Trading (Shanghai) Co., Ltd., initiated a voluntary recall of its Troponin-I Assay Kits (Chemiluminescent Microparticle Immunoassay), specifically batch number 74264UN11. This recall, reported to the National Medical Products Administration (NMPA) on April 16, 2012, stems from the discovery that certain batches experienced a reference value drift under specific conditions. While this drift varied in degree among kits and was detectable in quality control products, recalibration was found to restore accurate patient results if the quality control value exceeded the specified range. Under the oversight of the NMPA, Abbott's required actions include notifying customers to immediately cease selling and using the affected products. The recalled kits are slated for destruction. Furthermore, the NMPA requested that provincial, autonomous region, and municipal food and drug administrations enhance their supervision and management of similar products to ensure public safety and product quality. This proactive measure by Abbott addresses a potential accuracy issue in a critical diagnostic tool.