# China NMPA Product Recall - Diluent for blood cell analysis

Source: https://www.globalkeysolutions.net/records/china_product_recall/mindray-nanjing-biotechnology-co-ltd/7fdd841f-0b6d-4dcf-8e5f-f910d67459bc/
Source feed: China

> China NMPA product recall for Diluent for blood cell analysis by Mindray Nanjing Biotechnology Co., Ltd. published August 21, 2017. Recall level: Level 3 Recall. Mindray Nanjing Biotechnology Co., Ltd. voluntarily initiated a Level III recall for several diluent

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Mindray Nanjing Biotechnology Co., Ltd. voluntarily recalls diluents for blood cell analysis.
- Company Name: Mindray Nanjing Biotechnology Co., Ltd.
- Publication Date: 2017-08-21
- Product Name: Diluent for blood cell analysis
- Recall Level: Level 3 Recall
- Recall Reason: The label and instruction manual templates for some batches of hematology analyzer diluents did not include a "production date," which does not comply with relevant regulations.
- Discovering Company: Mindray Nanjing Biotechnology Co., Ltd.
- Manufacturing Company: Mindray Nanjing Biotechnology Co., Ltd.
- Summary: Mindray Nanjing Biotechnology Co., Ltd. voluntarily initiated a Level III recall for several diluents used in hematology analysis, as reported by the National Medical Products Administration (NMPA) on August 21, 2017. The recall stemmed from printing errors on the product labels and instructions for use, specifically the absence of a "Production Date:" field. Despite this labeling non-compliance, the company affirmed that the affected products (models DS, M-3D, M-5D, and M-68DR) were safe, with clear expiration dates provided, and their performance or customer use remained unaffected. As corrective action, Mindray Nanjing Biotechnology Co., Ltd. committed to notifying all impacted customers via a letter. This communication would detail the labeling discrepancy and guide customers on identifying the production date using the reagent batch number. Significantly, the recall did not require the return of any sold products, underscoring that the issue was one of regulatory labeling adherence rather than product safety or efficacy. The recall involved a substantial volume of products distributed within China.

Company: https://www.globalkeysolutions.net/companies/mindray-nanjing-biotechnology-co-ltd/270b13c1-e6f9-43e7-bc61-7336bbe44483/