China NMPA Product Recall - Lactate dehydrogenase assay kit (lactate substrate method)

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Lactate Dehydrogenase Assay Kit (Lactate Substrate Method) due to a critical inconsistency identified in the product's instruction manual. The recall, publicly announced on July 10, 2020, through the National Medical Products Administration (NMPA) framework, addresses a discrepancy between the English and Chinese versions of the manual. Specifically, the English version stated an open-bottle stability period of 21 days, while the Chinese version incorrectly indicated 30 days. This error poses a risk of incorrect product usage and potentially compromised diagnostic results, highlighting the importance of precise and consistent product documentation. As a result, Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. proactively initiated the recall to mitigate any potential adverse impacts on patient safety and diagnostic accuracy. Further details regarding specific product information and the scope of the recall are expected to be outlined in the "Medical Device Recall Event Report Form." This voluntary action underscores the company's commitment to regulatory compliance and product integrity under NMPA oversight.