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

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-zhongyuan-biotechnology-co-ltd/bf3eb87f-0d29-44bc-809f-ca1bc37501c7/
Source feed: China

> China NMPA product recall for α-Hydroxybutyrate dehydrogenase assay kit (rate method) by Chongqing Zhongyuan Biotechnology Co., Ltd. published October 22, 2020. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a notice detailing a voluntary Class I

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Zhongyuan Biotechnology Co., Ltd. is voluntarily recalling its α-hydroxybutyrate dehydrogenase assay kit (rate method), batch number Z170301, specifications R1 48mL×2 R2 12mL×2.
- Company Name: Chongqing Zhongyuan Biotechnology Co., Ltd.
- Publication Date: 2020-10-22
- Product Name: α-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: The National Medical Products Administration (NMPA) published a notice detailing a voluntary Class III recall initiated by Chongqing Zhongyuan Biotechnology Co., Ltd. Announced on October 22, 2020, the recall targets the company's ∝-Hydroxybutyrate Dehydrogenase Detection Kit (Rate Method), specifically Batch No. Z170301, with specifications R1 48mL×2 and R2 12mL×2. The core issue identified was the product's non-compliance with its registered product standards during testing. While explicit inspection dates are not provided, an attached "Medical Device Recall Event Report Form" is dated September 27, 2017, indicating the timeframe when the non-compliance was likely documented or discovered. This action falls under the regulatory oversight of the NMPA, with the recall information disseminated via the Chongqing Municipal Drug Administration Website. The required action for Chongqing Zhongyuan Biotechnology Co., Ltd. is a voluntary Class III recall to address the non-conforming product and uphold established quality and safety standards.

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