# China NMPA Product Recall - Creatine kinase isoenzyme assay kit (immunosuppression method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/54216008-c47f-4ebc-9e23-512b2f5e56dd/
Source feed: China

> China NMPA product recall for Creatine kinase isoenzyme assay kit (immunosuppression method) by Beckman Coulter Experimental Systems (Suzhou) Co., Ltd. published May 19, 2021. Recall level: Level 3 Recall. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Level III recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is voluntarily recalling its creatine kinase isoenzyme assay kit (immunosuppression method).
- Company Name: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Publication Date: 2021-05-19
- Product Name: Creatine kinase isoenzyme assay kit (immunosuppression method)
- Recall Level: Level 3 Recall
- Recall Reason: During internal interference testing, CK-MB was found to fail to meet the lipemia interference claim stated in the instructions for use (IFU) as "interference less than 20% at concentrations up to 900 mg/dL". It is anticipated that all batches of CK-MB will fail to meet the IFU issue.
- 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 III recall for its Creatine Kinase Isoenzyme Assay Kit (Immunoinhibition Method), specifically catalog number OSR61155. This action, reported to the Jiangsu Provincial Drug Administration under the National Medical Products Administration (NMPA) framework, stems from internal interference testing findings published on May 19, 2021. The company discovered that the CK-MB kit failed to consistently meet the specified lipemia interference performance described in its Instructions for Use (IFU).

The primary issue identified was that the kit did not achieve the stated "interference less than 20% at concentrations up to 900 mg/L" under certain lipemic conditions. While this deviation was noted, Beckman Coulter assessed the associated risk as "very low." The recall does not involve discontinuing the product. Instead, the company is implementing corrective actions, including issuing a Medical Device Recall Notice (FA-000) to inform customers about the updated lipemia interference data. Furthermore, Beckman Coulter plans to revise the IFU to reflect a modified lipemia interference statement of "interference less than 15%," ensuring accurate product information for users.

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