# China NMPA Product Recall - Immunochromogenic reagent Bond Polymer Refine Detection

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/13d2f0f1-ade2-41fe-accb-f0da7834dcca/
Source feed: China

> China NMPA product recall for Immunochromogenic reagent Bond Polymer Refine Detection by Leica Microsystems (Shanghai) Trading Co., Ltd. published March 30, 2021. Recall level: Level 3 Recall. Leica Microsystems (Shanghai) Trading Co., Ltd. issued a voluntary Class III recall for its Immunoch

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling its Bond Polymer Refine Detection immunochromatographic reagent.
- Company Name: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Publication Date: 2021-03-30
- Product Name: Immunochromogenic reagent Bond Polymer Refine Detection
- Recall Level: Level 3 Recall
- Recall Reason: Issues related to product mechanical compatibility with dyeing machines
- Discovering Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Summary: Leica Microsystems (Shanghai) Trading Co., Ltd. issued a voluntary Class III recall for its Immunochromogenic Reagent Bond Polymer Refine Detection product, as reported by the National Medical Products Administration (NMPA) on March 30, 2021. The recall stems from identified mechanical compatibility issues affecting the product's use with staining machines. This specific reagent is registered under Certificate No.: 20150558. The company communicated this action through the Shanghai Municipal Drug Administration, operating within the NMPA's regulatory framework. A Class III recall indicates that the product's use is not likely to cause significant adverse health consequences. Full details concerning the affected product's model, specifications, and batch numbers are available in the accompanying 'Medical Device Recall Event Report Form.' This measure underscores Leica Microsystems' commitment to product quality and compliance with NMPA's stringent medical device regulations, emphasizing the critical need for complete compatibility assessments of diagnostic reagents and associated equipment.

Company: https://www.globalkeysolutions.net/companies/leica-microsystems-shanghai-trading-co-ltd/a190d1a7-ccd3-4a6e-9490-3b9fd63aa553/