# China NMPA Product Recall - Creatine kinase assay kit (enzyme-coupled method), creatine kinase isoenzyme assay kit (immunosuppression method)

Source: https://www.keypedia.com/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/6917a9eb-552e-4632-8fab-e425cfeb24b7
Source feed: China

> China NMPA product recall for Creatine kinase assay kit (enzyme-coupled method), creatine kinase isoenzyme assay kit (immunosuppression method) by Beckman Coulter Experimental Systems (Suzhou) Co., Ltd. published July 19, 2017. Recall level: Level 3 Recall. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level 3 recall for its C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is voluntarily recalling its creatine kinase assay kits (enzyme-coupled method) and creatine kinase isoenzyme assay kits (immunosuppression method).
- Company Name: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Publication Date: 2017-07-19
- Product Name: Creatine kinase assay kit (enzyme-coupled method), creatine kinase isoenzyme assay kit (immunosuppression method)
- Recall Level: Level 3 Recall
- Recall Reason: The registration certificate number on the outer label is printed incorrectly and does not comply with regulations.
- Discovering Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Manufacturing Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Summary: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level 3 recall for its Creatine Kinase Assay Kit (Enzyme-Conjugated Method) and Creatine Kinase Isoenzyme Assay Kit (Immunoinhibition Method). This recall, reported on June 1, 2017, and published by the National Medical Products Administration (NMPA) on July 19, 2017, addresses a labelling inaccuracy. The primary issue identified was the incorrect printing of the registration certificate number on the outer label of specific reagent kits (Registration Numbers: Su Medical Device Registration Certificate 20162401311 and 20162401310). While the company affirmed that all other product information was accurate and the defect did not impact the safety or efficacy of the product for customer use, the mislabeling constitutes a non-compliance with NMPA regulatory requirements. Under the Chinese regulatory framework for medical devices, the company was required to undertake several corrective actions. These included promptly notifying all affected customers, isolating all unsold units of the identified batches (AUZ4225 and AUZ4242), and facilitating the recall of all sold reagents to arrange for returns and exchanges. This voluntary action demonstrates the company's commitment to regulatory adherence, even for issues not directly impacting product performance.

Company: https://www.keypedia.com/companies/beckman-coulter-experimental-systems-suzhou-co-ltd/b1bdab62-43a3-4af1-902c-04b2a6e0e660