China NMPA Product Recall - Lactate Assay Kit (Lactate Oxidase Method)

On December 7, 2016, the National Medical Products Administration (NMPA) published details of a voluntary Class II medical device recall initiated by Abbott Trading (Shanghai) Co., Ltd., on behalf of Abbott Laboratories. The recall targets specific batches of their Lactate Assay Kit (Lactate Oxidase Method), an in-vitro diagnostic product used for the quantitative determination of lactate in human plasma.

The core issue, identified through an internal investigation by Abbott Diagnostics headquarters and reported on October 13, 2016, revealed that the drug N-acetylcysteine (NAC) interferes with the affected lactate assay kits. This interference has the potential to cause falsely low lactate test results. While the company had not received any patient complaints globally regarding this issue at the time of the report, the potential for inaccurate results prompted the recall.

Under the NMPA's regulatory framework, Abbott Trading (Shanghai) Co., Ltd. initiated a global recall. The required action involved immediately notifying all affected customers via a customer letter. This communication informed users about the N-acetylcysteine interference and advised them on the continued use of the kits in accordance with the provided guidance. Notably, this recall did not involve the physical return of products by customers. A total of 227 boxes of the affected product, spanning various batch numbers, were sold within China.