# China NMPA Product Recall - Immunoglobulin M Detection Kit (Immunoturbidimetric Assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/bc65ad75-65c3-4946-ae23-d1e430485a3d/
Source feed: China

> China NMPA product recall for Immunoglobulin M Detection Kit (Immunoturbidimetric Assay) by Beckman Coulter Trading (China) Co., Ltd. published May 20, 2019. Recall level: Level 3. On May 20, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. is voluntarily recalling its Immunoglobulin M Detection Kit (Immunoturbidimetric Assay).
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-05-20
- Product Name: Immunoglobulin M Detection Kit (Immunoturbidimetric Assay)
- Recall Level: Level 3
- Recall Reason: The product in question may generate error messages E60 (no reaction, antigen overload detection failed) or E66 (unstable reaction) at extremely low concentrations of patient samples (the results are unaffected for patient samples that do not generate error messages).
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On May 20, 2019, Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Level III recall of its Immunoglobulin M Detection Kit (Immunoturbidimetric Assay). This action was reported under the National Medical Products Administration (NMPA) Administration Index No. JGXX-2019-10322.
The recall stems from a product performance issue where the detection kit may generate specific error messages, E60 ("no reaction, antigen overload detection failure") or E66 ("unstable reaction"), when used to test patient samples with very low concentrations. It is important to note that this issue is specifically linked to the appearance of these error messages and does not reportedly impact the accuracy of results for patient samples that do not trigger such errors.
In response to this identified issue, Beckman Coulter Trading (China) Co., Ltd. proactively engaged in this voluntary recall to address the potential for misleading error messages during testing. The company has made detailed information regarding the affected product models, specifications, and batch numbers available in an accompanying "Medical Device Recall Event Report Form" for stakeholders and customers to review. This measure ensures transparency and facilitates the appropriate handling of the affected kits in accordance with regulatory expectations set by the NMPA.

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