China NMPA Product Recall - buffer solution

Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiated a voluntary Level III recall of specific buffer solutions, announced on July 19, 2017. This action, reported to the National Medical Products Administration (NMPA) within China's medical device regulatory framework, was due to a labeling error on 8 batches, totaling 54,768 boxes. The primary issue was an incorrect "Production Registration Number" printed on the product labels, a typographical error in the name of the issuing regulatory body. While this misprint did not affect the product's safety, effectiveness, or customer use, it represented a non-compliance with regulatory labeling requirements. As part of the required actions, unshipped products were isolated, relabeled correctly, and verified before being released for sale. Products already dispatched to the general distributor but not yet in the market were subject to distributor notification for isolation and label correction. Customer notification was not deemed necessary as the products had not reached end-users. This recall focused solely on rectifying administrative labeling inaccuracies.