China NMPA Product Recall - buffer solution

On July 18, 2017, the National Medical Products Administration (NMPA) announced that Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. was voluntarily recalling specific batches of its manufactured buffer solutions. This Level III recall, initiated by the company on June 26, 2017, stemmed from a typographical error on the product labels. The incorrect "Production Registration Number" was printed, displaying "Susu Drug Administration Medical Device Production Registration 20152014" instead of the accurate "Susu Food and Drug Administration Medical Device Production Registration 20152014." This issue affected eight batches, totaling 54,768 boxes, distributed within China. While the error did not compromise product safety, effectiveness, or user experience, it failed to meet regulatory requirements, prompting the recall under the NMPA and Provincial Food and Drug Administration framework. Corrective actions included isolating and reworking unshipped products to rectify the labels before release. For products already shipped to distributors but not yet to end-users, the general distributor was instructed to isolate inventory and correct labeling errors. Products could only be further distributed after these corrections were verified. As products had not reached the market, direct customer notification was deemed unnecessary.