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

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a Class II voluntary recall for specific batches of Lithium Assay Dry Tablets (Colorimetric Method), manufactured by Ortho-Clinical Diagnostics, Inc. and distributed by Ortho-Clinical Diagnostics Trading (China) Co., Ltd. The National Medical Products Administration (NMPA) publicly reported this recall on March 17, 2017, following a recall event report submitted on February 20, 2017. The primary concern was the discovery that two batches of the lithium assay tablets, specifically 3124-0108-6568 and 3124-0108-6569, might produce an intermittent result bias. This inaccuracy could affect consecutive tablets within or between tablet cassettes, potentially compromising the accurate quantitative determination of lithium content in serum and plasma. As a corrective action, all affected distributors were instructed to immediately cease distribution and discard any remaining stock of the identified product batches. Ausendo Medical Devices Trading (China) Co., Ltd. committed to providing replacement products to those impacted, demonstrating adherence to regulatory standards and a commitment to patient safety under NMPA oversight.