# China NMPA Product Recall - Magnesium Assay Kit (Xyleneamine Blue Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/c2dd9e7e-56e7-41c9-9b70-dfa04412915c/
Source feed: China

> China NMPA product recall for Magnesium Assay Kit (Xyleneamine Blue Method) by Beckman Coulter Trading (China) Co., Ltd. published December 13, 2021. Recall level: Level 3 Recall. On December 13, 2021, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III reca

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its magnesium assay kit (xyleneamine blue method).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2021-12-13
- Product Name: Magnesium Assay Kit (Xyleneamine Blue Method)
- Recall Level: Level 3 Recall
- Recall Reason: 1. The magnesium assay kit did not meet the serum lipemia interference quality standard defined in the instructions for use, namely, interference of less than 10% at a fat emulsion concentration as high as 500 mg/dL. 2. The sample pools for both levels of the magnesium assay kit exceeded the quality standard, with a maximum bias of +30.38% for the low level (0.82 mmol/L) and +13.56% for the high level (2.06 mmol/L).
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On December 13, 2021, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall of its Magnesium Assay Kit (Xyleneamine Blue Method), identified by Registration Certificate No.: 20142405732. This action was reported to the National Medical Products Administration (NMPA). The recall stems from internal interference testing conducted as part of an in vitro diagnostic medical device regulation (IVDR) remedial project, adhering to CLSI Guideline EP07 Version 3. The company discovered that the assay kit failed to meet the specified serum application lipemia interference quality standard outlined in its instructions for use. Specifically, the kit's performance exceeded the acceptable interference limit of less than 10% at a fat emulsion concentration up to 500 mg/dL. Testing revealed significant biases: a low-level analyte sample pool (0.82 mmol/L) showed a maximum bias of +30.38%, and a high-level sample pool (2.06 mmol/L) showed a maximum bias of +13.56%. Beckman Coulter Trading (China) Co., Ltd. is taking required actions by voluntarily recalling the affected product. Further details on specific models, specifications, and batch numbers are available in the associated Medical Device Recall Event Report Form.

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