# China NMPA Product Recall - Creatine kinase isoenzyme (CK-MB) assay kit (enzyme-mediated immunosuppression method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/c537f4ea-8b1f-46c6-8c42-21ee47a214a9
Source feed: China

> China NMPA product recall for Creatine kinase isoenzyme (CK-MB) assay kit (enzyme-mediated immunosuppression method) by Beckman Coulter Trading (China) Co., Ltd. published May 14, 2021. Recall level: Level 3. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Creatine Ki

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its creatine kinase isoenzyme (CK-MB) assay kit (enzyme-mediated immunosuppression method).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2021-05-14
- Product Name: Creatine kinase isoenzyme (CK-MB) assay kit (enzyme-mediated immunosuppression method)
- Recall Level: Level 3
- Recall Reason: The product in question, CK-MB (catalog number OSR61155), failed to meet the lipemia interference claim stated in the Instructions for Use (IFU) as "less than 20% intralipid interference at concentrations below 900 mg/dL". It is anticipated that all batches of CK-MB are likely to exhibit similar lipemia interference issues during testing.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Creatine Kinase Isoenzyme (CK-MB) Detection Kit (Enzyme Immunoinhibition Method), catalog number OSR61155. This action, published on May 14, 2021, follows internal interference testing that revealed the product failed to meet the specified lipemia interference statement in its Instructions for Use. The core issue was that the kit did not maintain intralipid interference below 20% when lipemia was under 900 mg/dL, contrary to its stated performance. The company anticipates that all batches of the CK-MB kit will exhibit similar interference problems. While this deviation affects the product's performance specifications, Beckman Coulter assessed the risk to patient safety from potentially delayed or inaccurate results as "very low." The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, adhering to established medical device regulatory frameworks in China. As a required action, the company is voluntarily recalling all affected creatine kinase isoenzyme assay kits, with specific details on models, specifications, and batches made available in an accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad