# China NMPA Product Recall - Apolipoprotein B Assay Kit (Immunoturbidimetric Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/34a62a5d-70f6-48d7-b92b-c280226977ee/
Source feed: China

> China NMPA product recall for Apolipoprotein B Assay Kit (Immunoturbidimetric Method) by Beckman Coulter Trading (China) Co., Ltd. published June 29, 2019. Recall level: Level 3 Recall. On June 29, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall o

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its apolipoprotein B assay kit (immunoturbidimetric assay).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-06-29
- Product Name: Apolipoprotein B Assay Kit (Immunoturbidimetric Method)
- Recall Level: Level 3 Recall
- Recall Reason: The product in question, batch M810066, Apolipoprotein B Assay Kit (Immunoturbidimetric Assay) (ApoB), contained incorrect APOB calibration solution set point target values in its important product information insert.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On June 29, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Apolipoprotein B Assay Kit (Immunoturbidimetric Assay), specifically affecting batch M810066. This action was prompted by the discovery of incorrect setpoint target values for the Apolipoprotein B (APOB) calibration solution, which were detailed in the product's important information. The issue could potentially lead to inaccurate test results when using the affected kits. The recall was reported by the Shanghai Food and Drug Administration and overseen by the National Medical Products Administration (NMPA) of China, indicating adherence to national medical device safety regulations. The company voluntarily undertook this recall to address the quality deviation and ensure product reliability. While the specific detailed actions beyond the recall itself, such as product return or replacement procedures, are not outlined in this public notice, further information was made available in a Medical Device Recall Event Report Form. This recall underscores the company's responsibility in maintaining product quality and compliance with regulatory standards set by the NMPA, safeguarding patient diagnostic accuracy.

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