# China NMPA Product Recall - Lactate dehydrogenase assay kit (lactate substrate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/15f2930f-9987-49f4-9730-ea46dbb4db43/
Source feed: China

> China NMPA product recall for Lactate dehydrogenase assay kit (lactate substrate method) by Beckman Coulter Experimental Systems (Suzhou) Co., Ltd. published July 10, 2020. Recall level: Level 3 Recall. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is voluntarily recalling its lactate dehydrogenase assay kit (lactate substrate method).
- Company Name: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Publication Date: 2020-07-10
- Product Name: Lactate dehydrogenase assay kit (lactate substrate method)
- Recall Level: Level 3 Recall
- Recall Reason: The instructions for the Lactate Dehydrogenase Assay Kit (Lactate Substrate Method) state that the open-bottle stability is 21 days in the English version and 30 days in the Chinese version, which is inconsistent.
- Discovering Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Manufacturing Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Summary: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a voluntary Class III recall for its Lactate Dehydrogenase Assay Kit (Lactate Substrate Method) due to a critical inconsistency identified in the product's instruction manual. The recall, publicly announced on July 10, 2020, through the National Medical Products Administration (NMPA) framework, addresses a discrepancy between the English and Chinese versions of the manual. Specifically, the English version stated an open-bottle stability period of 21 days, while the Chinese version incorrectly indicated 30 days. This error poses a risk of incorrect product usage and potentially compromised diagnostic results, highlighting the importance of precise and consistent product documentation. As a result, Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. proactively initiated the recall to mitigate any potential adverse impacts on patient safety and diagnostic accuracy. Further details regarding specific product information and the scope of the recall are expected to be outlined in the "Medical Device Recall Event Report Form." This voluntary action underscores the company's commitment to regulatory compliance and product integrity under NMPA oversight.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-experimental-systems-suzhou-co-ltd/b1bdab62-43a3-4af1-902c-04b2a6e0e660/