China NMPA Product Recall - Low-density lipoprotein assay kit (one-step immunoturbidimetric method)

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Low-Density Lipoprotein Assay Kit (Immunoturbidimetric One-Step Method). This action, publicized by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration on December 5, 2018, stemmed from reports of performance issues related to the 26th and 27th generation batches of the diagnostic product. While no specific regulatory inspection dates were detailed, the company conducted internal testing on a new batch following these complaints, leading to the decision to recall. The recalled kits, identified under Registration Certificate No. 20182401588, are critical for measuring low-density lipoprotein levels, a key indicator in cardiovascular health assessments. Ausendo's proactive voluntary recall demonstrates adherence to China's medical device regulations, aiming to ensure the safety and efficacy of its products. The Level III classification indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further comprehensive details regarding the specific models, specifications, and affected batch numbers are documented in the "Medical Device Recall Event Report Form" associated with NMPA Index No. JGXX-2018-11401. This recall ensures that potentially non-conforming products are removed from circulation to protect public health.