China NMPA Product Recall - Lithium determination using dry slides (colorimetric method)

Ausendo Medical Devices Trading (China) Co., Ltd., collaborating with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall for specific batches of its Lithium Assay Dry Tablets (Colorimetric Method). This action was reported on February 20, 2017, and subsequently published by the National Medical Products Administration (NMPA) on April 6, 2017. The primary concern identified was an intermittent result bias affecting two batches, 3124-0108-6568 and 3124-0108-6569. These tablets are critical for the quantitative determination of lithium in serum and plasma. The inaccuracy was noted to affect consecutive tablets, potentially impacting diagnostic reliability. While one affected product (1632660) had no units imported or sold in China, three boxes of product 8318925 were imported and sold. The recall's scope is global. Under the NMPA's classification, a Class II recall indicates a situation where product use may cause temporary or reversible adverse health consequences, or where serious consequences are remote. As required actions, distributors were instructed to immediately halt distribution and discard all remaining stock of the affected batches. Ausendo Medical Devices Trading (China) Co., Ltd. pledged to provide replacement products, ensuring the integrity and accuracy of diagnostic testing.