China NMPA Product Recall - Sample diluent

Ausendo Clinical Diagnostics (UK) Ltd., in conjunction with its Chinese distributor, Ausendo Medical Device Trading (China) Co., Ltd., has initiated a voluntary Class III recall of specific batches of its sample diluent. The recall, reported on December 10, 2021, was prompted by an identified issue where the sample diluent caused lower-than-expected results when used with the thyroid-stimulating hormone assay kit (chemiluminescence method). This finding could potentially impact the accuracy of diagnostic testing.

Operating under the oversight of the National Medical Products Administration (NMPA) in China, this voluntary action aims to address the product's performance discrepancy. The regulatory framework designates this as a Class III recall, indicating that the use of or exposure to a violative product is not likely to cause adverse health consequences.

As a required action, Ausendo Clinical Diagnostics (UK) Ltd. is recalling the affected sample diluent (Registration Certificate Code: 20160738). Further detailed information regarding the specific models and batch numbers involved is available in the "Medical Device Recall Event Report Form" for stakeholders and customers to identify and manage affected inventory. The company is committed to ensuring product quality and patient safety through this corrective measure.