China NMPA Product Recall - N-terminal brain natriuretic peptide assay kit (chemiluminescence method)

Ausendo Medical Devices Trading (China) Co., Ltd. initiated a voluntary recall of its N-terminal Brain Natriuretic Peptide Assay Kits, as reported by the National Medical Products Administration (NMPA) on May 8, 2017. The recall pertains to specific batches of the diagnostic product, which were identified to have an elevated incidence of calibration failures. A primary concern was the unexpected increase in the signal of Level 1 calibrators, a defect that could result in inaccurate calibration parameters. This issue potentially compromises the reliability of test results obtained using the affected kits, which are crucial for medical diagnoses. The company undertook this action in accordance with NMPA regulations, classifying it as a Level III recall. While the document does not specify an inspection date, the recall itself reflects the company's response to detected product performance issues. A Level III recall typically indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information regarding the models, specifications, and batch numbers of the impacted products is available in the associated "Medical Device Recall Event Report Form." This proactive measure by Ausendo Medical Devices Trading (China) Co., Ltd. demonstrates adherence to product safety and quality standards under the NMPA framework.