# China NMPA Product Recall - Urine analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/kyoto-hongyi-biotechnology-suzhou-co-ltd/fc2c6333-4e23-4e35-aaa4-5dce1ceba5d3/
Source feed: China

> China NMPA product recall for Urine analyzer by Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd. published February 07, 2021. Recall level: Level 3 Recall. Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd. initiated a Level III voluntary recall for specific ba

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd. voluntarily recalls urine analyzers
- Company Name: Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd.
- Publication Date: 2021-02-07
- Product Name: Urine analyzer
- Recall Level: Level 3 Recall
- Recall Reason: Production based on design changes does not meet the technical requirements for registered products.
- Discovering Company: Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd.
- Manufacturing Company: Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd.
- Summary: Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd. initiated a Level III voluntary recall for specific batches of its Urine Analyzers (models HY-50 and HY-500A), as reported by the National Medical Products Administration (NMPA) on February 7, 2021. The recall addresses a critical compliance issue: 30 units across both models (20 HY-50 and 10 HY-500A) were manufactured following design changes that resulted in their non-conformance with the technical requirements for registered medical devices. The company identified that these products, intended for clinical urinalysis in conjunction with the company's test strips, did not meet approved specifications.

This voluntary action falls under the oversight of the NMPA and the Jiangsu Provincial Drug Administration, highlighting a commitment to regulatory standards within China. In response to this deficiency, Kyoto Hongyi Biotechnology (Suzhou) Co., Ltd. is implementing several corrective measures. These include dispatching "Medical Device Incident Notifications" to all distributors of the affected batches, detailing the issue and necessary actions. The company is also actively recalling all identified non-conforming units from distributors, providing clear guidelines for their return and proper disposal. Furthermore, a comprehensive review of the urine analyzer's technical requirements and instructions is underway to prevent similar deviations in the future, ensuring product quality and regulatory adherence.

Company: https://www.globalkeysolutions.net/companies/kyoto-hongyi-biotechnology-suzhou-co-ltd/f8e6fee1-7c21-48dd-8233-ffb005773bd4/