# China NMPA Product Recall - ∝-Hydroxybutyrate dehydrogenase assay kit (rate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-zhongyuan-biotechnology-co-ltd/2513b471-add7-44fb-860a-94d0718c7493/
Source feed: China

> China NMPA product recall for ∝-Hydroxybutyrate dehydrogenase assay kit (rate method) by Chongqing Zhongyuan Biotechnology Co., Ltd. published September 29, 2017. Recall level: Level 3 Recall. Chongqing Zhongyuan Biotechnology Co., Ltd. initiated a voluntary Level III recall for its ∝-Hydroxy

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Zhongyuan Biotechnology Co., Ltd. is voluntarily recalling its α-hydroxybutyrate dehydrogenase detection kit (rate method), batch number Z170301, specifications R1 48mL×2 R2 12mL×2.
- Company Name: Chongqing Zhongyuan Biotechnology Co., Ltd.
- Publication Date: 2017-09-29
- Product Name: ∝-Hydroxybutyrate dehydrogenase assay kit (rate method)
- Recall Level: Level 3 Recall
- Recall Reason: The product testing items of the enterprise do not meet the requirements of the registered product standard.
- Discovering Company: Chongqing Zhongyuan Biotechnology Co., Ltd.
- Manufacturing Company: Chongqing Zhongyuan Biotechnology Co., Ltd.
- Summary: Chongqing Zhongyuan Biotechnology Co., Ltd. initiated a voluntary Level III recall for its ∝-Hydroxybutyrate Dehydrogenase Detection Kit (Rate Method), specifically Batch No. Z170301 with specifications R1 48mL×2 and R2 12mL×2. The company took this action because internal product testing revealed that items within this batch did not meet the established registered product standard requirements, indicating a significant quality deviation. This recall was formally reported on September 27, 2017, and subsequently publicized by the National Medical Products Administration (NMPA) on September 29, 2017. While specific inspection dates are not detailed, the prompt recall reflects the company's response to its quality control findings. Under the regulatory oversight of the NMPA, Chongqing Zhongyuan Biotechnology Co., Ltd. is required to manage the retrieval and proper handling of all affected kits from the market to ensure public safety and adherence to product standards.

Company: https://www.globalkeysolutions.net/companies/chongqing-zhongyuan-biotechnology-co-ltd/43c1fc5e-9e57-4074-97a9-02622d98e179/