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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/5ff9a195-dc14-488c-8fc4-96320a6c06df/
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 18, 2017. Recall level: Level 3. 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: 2017-07-18
- Product Name: Creatine kinase assay kit (enzyme-coupled method), creatine kinase isoenzyme assay kit (immunosuppression method)
- Recall Level: Level 3
- Recall Reason: The above-mentioned batch of products had an incorrectly printed registration certificate number on the outer label of the reagent kit; all other information was correct. Therefore, it does not affect customer use. Although there are no product usage issues, it does not meet regulatory requirements, hence the recall.
- 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 was reported on June 1, 2017, and officially published by the National Medical Products Administration (NMPA) on July 18, 2017.

The main issue leading to the recall was an incorrectly printed registration certificate number on the outer label of specific reagent kits. Affected batches included AUZ4225 for product OSR6279 and AUZ4242 for product OSR61155. While the company confirmed that this labeling discrepancy did not impact the product's functionality or customer use, it represented a non-compliance with NMPA's regulatory requirements, thus necessitating the recall.

As part of the corrective actions, Beckman Coulter was mandated to notify all affected customers, ensure the isolation of any unsold reagents from the identified batches, and manage the recall of all sold reagents, providing options for returns and exchanges. This action underscores the necessity of accurate labeling and strict adherence to regulatory standards, even for issues that do not directly compromise product efficacy.

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