China NMPA Product Recall - buffer solution

Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiated a voluntary Class III recall of its buffer solutions, as reported on July 2, 2017, stemming from a June 26, 2017, internal report. The recall affects 54,768 boxes across eight production batches, including Item Number 07981210014, distributed in China. The primary issue was a printing error on the product labels, specifically an incorrect "Production Registration Number." The labels mistakenly displayed "Susu Drug Administration Medical Device Production Registration 20152014" instead of the accurate "Susu Food and Drug Administration Medical Device Production Registration 20152014." Although the company confirmed this typographical error had no impact on the product's safety, effectiveness, or customer use, it violated regulatory requirements established by the National Medical Products Administration (NMPA) in China. Required actions included isolating and relabeling all unshipped products before release. For products already shipped to the main distributor but not yet released to the market, the distributor was instructed to isolate and correct the labels prior to any further distribution to lower-level dealers or end-users. No direct customer notification was necessary, as the products had not yet reached consumers.