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

Ausendo Medical Devices Trading (China) Co., Ltd., in conjunction with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall of two specific batches of Lithium Assay Dry Tablets (Colorimetric Method) on April 10, 2017. The recall was prompted by the discovery that these batches could produce intermittent result bias, affecting entire dry sheets or consecutive sheets within a box, rather than isolated instances. The affected products were imported globally, with 3 boxes of batch 8318925 sold in China. This action was reported to the National Medical Products Administration (NMPA), China's regulatory authority for medical devices. As a required action, distributors were instructed to immediately cease distribution and discard all remaining stock of the problematic batches. Ausendo Medical Devices Trading (China) Co., Ltd. committed to providing replacements for all affected products.