# China NMPA Product Recall - Creatine kinase assay kit (creatine phosphate substrate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/aaf21512-16c9-4a98-b28e-6357e4c9592f/
Source feed: China

> China NMPA product recall for Creatine kinase assay kit (creatine phosphate substrate method) by Siemens Healthcare Diagnostics Inc. published May 24, 2019. Recall level: Level 3. The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. is voluntarily recalling its creatine kinase assay kits (creatine phosphate substrate method).
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2019-05-24
- Product Name: Creatine kinase assay kit (creatine phosphate substrate method)
- Recall Level: Level 3
- Recall Reason: When using the above batch of creatine kinase assay kits (phosphocreatine substrate method) for testing, the results may be variable due to calibration failure.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Siemens Healthcare Diagnostics Inc. for its Creatine Kinase Assay Kits (Creatine Phosphosubstrate Method), Registration Certificate No. 20182400427. This recall, reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., stemmed from a critical issue: calibration failure, which resulted in variable and unreliable test outcomes from the affected batches. The assay kits are intended for in vitro quantitative determination of creatine kinase in human serum and plasma. The recall was formally reported on May 13, 2019, and publicly disclosed on May 24, 2019. Specific product models and batches were identified, impacting regions including the United States and Canada, although no affected batches were imported into China. As a required action, Siemens Healthcare Diagnostics Inc. issued an Emergency Field Safety Notice (UFSN) to customers in the affected countries, instructing them to immediately cease using and properly discard the problematic batches. This measure was implemented to mitigate risks associated with inaccurate diagnostic results.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/