# China NMPA Product Recall - buffer solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/thermo-fisher-scientific-suzhou-instruments-co-ltd/8af5edc7-9785-444b-baed-bf391690e411/
Source feed: China

> China NMPA product recall for buffer solution by Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd. published July 18, 2017. Recall level: Level 3 Recall. On July 18, 2017, the National Medical Products Administration (NMPA) announced that Thermo Fisher S

---

## 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: 2017-07-18
- Product Name: buffer solution
- Recall Level: Level 3 Recall
- Recall Reason: The product label is printed incorrectly. The production registration information shows "Production Registration Number: Susu Drug Administration Medical Device Production Registration 20152014," which should actually be "Production Registration Number: Susu Food and Drug Administration Medical Device Production Registration 20152014." This error does not affect the product's safety and efficacy, but a recall has been initiated due to non-compliance with regulatory requirements.
- Discovering Company: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd.
- Manufacturing Company: Thermo Fisher Scientific (Suzhou) Instruments Co., Ltd.
- Summary: 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.

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