# China NMPA Product Recall - Lipase Assay Kit (Enzymatic Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/002b4ab0-8fe2-4647-b28e-ed87ecebd424/
Source feed: China

> China NMPA product recall for Lipase Assay Kit (Enzymatic Method) by Beckman Coulter, Inc. published October 22, 2018. Recall level: Level 3 Recall. Beckman Coulter, Inc., in cooperation with its agent Beckman Coulter Trading (China) Co., Ltd., init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter, Inc. is voluntarily recalling its lipase assay kits (enzymatic method).
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2018-10-22
- Product Name: Lipase Assay Kit (Enzymatic Method)
- Recall Level: Level 3 Recall
- Recall Reason: Using the M712448 batch of lipase assay kit (enzymatic method) to test quality control and patient samples may result in lower recovery rates than previous batches. Lower recovery rates of the lipase (LIP) reagent during quality control testing may exceed the lower limit of the laboratory's established QC range or the target range. This issue has virtually no impact on clinical diagnosis, therefore retrospective review of patient results is not required.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter, Inc., in cooperation with its agent Beckman Coulter Trading (China) Co., Ltd., initiated a voluntary Class III recall of its Lipase Assay Kit (Enzymatic Method). The recall, reported to the National Medical Products Administration (NMPA) on September 25, 2018, was prompted by concerns regarding batch M712448. Testing revealed that this specific batch exhibited a lower recovery rate compared to previous lots when used for quality control and patient sample analysis. This issue could cause quality control results to fall below the laboratory's established lower limit. However, the manufacturer determined that the clinical impact on patient diagnosis is minimal, therefore retrospective review of patient results is not required. While the affected products (batch M712448) were not sold in China, the recall impacts regions including the USA, Canada, and Italy. The action reflects adherence to regulatory frameworks to address product performance deviations and ensure medical device reliability.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/