China NMPA Product Recall - haptoglobin assay kit (immunoturbidimetric method)

Ortho-Clinical Diagnostics, Inc. initiated a voluntary recall of specific batches of its Haptoglobin Assay Kits (Immunoturbidimetric Assay). This action, publicized on November 26, 2012, follows reports from customers, channeled through Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue involved increased condition codes, which either prevented the calibration of certain product batches or led to unreliable or unobtainable results when processing patient samples and quality control solutions. This defect potentially compromises the accuracy of diagnostic testing. The affected products were registered under CFDA (Imported) 2010 No. 2402877, indicating oversight by the National Medical Products Administration (NMPA) framework. Although Ortho-Clinical Diagnostics, Inc. stated that this specific recall does not directly involve the Chinese market, the NMPA proactively requested all provincial, autonomous region, and municipality food and drug administrations to enhance their supervision and management over similar medical devices. This demonstrates a regulatory emphasis on ensuring product quality and patient safety, even for products with a global distribution that might not be directly recalled within Chinese borders.