# China NMPA Product Recall - buffer solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-suzhou-instruments-co-ltd/0e97ee09-def1-4cfe-86be-4a7e1d9cf3d8/
Source feed: China

> China NMPA product recall for buffer solution by Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. published July 19, 2017. Recall level: Level 3 Recall. Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiated a voluntary Level III recall of sp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiates voluntary recall of buffer solutions.
- Company Name: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd.
- Publication Date: 2017-07-19
- Product Name: buffer solution
- Recall Level: Level 3 Recall
- Recall Reason: The production registration information on the labels of the aforementioned batch of products is printed incorrectly, displaying "Production Registration Number: SuSu Drug Administration Medical Device Production Registration 20152014," which is a typographical error. The correct information should be "Production Registration Number: SuSu Food and Drug Administration Medical Device Production Registration 20152014." This error does not affect the safety or effectiveness of the product, nor does it affect customer use. Although there are no product usage issues, it does not comply with regulatory requirements; therefore, a recall is initiated.
- Discovering Company: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/thermo-fisher-scientific-suzhou-instruments-co-ltd/bdd437b8-693b-43d6-85fe-44e1a0e2225e/