# China NMPA Product Recall - buffer solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-suzhou-instruments-co-ltd/ff93039a-73bd-43c3-b3ff-7b138c56305c/
Source feed: China

> China NMPA product recall for buffer solution by Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. published July 02, 2017. Recall level: Level 3. Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. initiated a voluntary Class III recall of it

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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: 2017-07-02
- Product Name: buffer solution
- Recall Level: Level 3
- 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, this product does not meet 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 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.

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