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

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall on February 20, 2017, concerning specific batches of Lithium Assay Dry Tablets (Colorimetric Method). This product, manufactured by Ortho-Clinical Diagnostics, Inc. with Ortho-Clinical Diagnostics Trading (China) Co., Ltd. serving as the responsible unit in China, was found to exhibit an intermittent result bias. The main issue identified was that two affected batches (3124-0108-6568 and 3124-0108-6569) could produce inaccurate results, particularly affecting consecutive tablets within or between cassettes, rather than isolated individual tablets. This could lead to unreliable lithium level determinations in serum and plasma.

Operating under the oversight of the National Medical Products Administration (NMPA), the company implemented immediate corrective actions globally. Affected distributors were instructed to promptly cease further distribution and safely dispose of all remaining stock from the implicated batches. Ausendo Medical Devices Trading (China) Co., Ltd. committed to providing replacement products to mitigate the impact on customers. This decisive action underscores the companies' commitment to product reliability and patient safety by addressing the identified performance inconsistencies.