# China NMPA Product Recall - Immunoglobulin G Detection Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/7c906794-3a70-44b7-befc-726304b7ce47
Source feed: China

> China NMPA product recall for Immunoglobulin G Detection Kit by Beckman Coulter Trading (China) Co., Ltd. published May 08, 2017. Recall level: Level III. Beckman Coulter Trading (China) Co., Ltd. initiated a voluntary Class III recall for its Immunoglobu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has voluntarily recalled its immunoglobulin G detection kits.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Immunoglobulin G Detection Kit
- Recall Level: Level III
- Recall Reason: The parameter card barcode in the immunoglobulin G assay kit with batch number M610132A does not contain the suffix "A". This mismatch between the parameter card barcode and the kit caused an error alarm stating "Parameter not found".
- 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 Immunoglobulin G Detection Kits. This recall, reported on May 8, 2017, and overseen by the National Medical Products Administration (NMPA), addresses a critical issue identified in products from batch number M610132A. The company discovered a significant discrepancy where the parameter card barcode within the affected kits lacked the necessary suffix "A". This specific mismatch between the parameter card barcode and the kit itself resulted in an operational error, triggering a "Parameter Not Found" alarm. To ensure patient safety and product reliability, Beckman Coulter Trading (China) Co., Ltd. has taken proactive measures to recall the relevant products. Further detailed information regarding the models, specifications, and specific batches of the affected medical devices is 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