# China NMPA Product Recall - Fully Automated IHC and ISH Staining System

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/e324ec3e-c666-4869-a577-c986e714f958/
Source feed: China

> China NMPA product recall for Fully Automated IHC and ISH Staining System by Leica Microsystems (Shanghai) Trading Co., Ltd. published July 05, 2021. Recall level: Level 3 Recall. Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of a batch of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling its Fully Automated IHC and ISH Staining Systems.
- Company Name: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Publication Date: 2021-07-05
- Product Name: Fully Automated IHC and ISH Staining System
- Recall Level: Level 3 Recall
- Recall Reason: In certain situations, batches of products may encounter reading errors when identifying the loaded reagent kits.
- Discovering Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Summary: Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of a batch of its Fully Automated IHC and ISH Staining System. This action, reported on July 5, 2021, was undertaken due to a critical technical issue: a potential reading error in the identification of loaded reagent kits under specific operating conditions. This malfunction could compromise the accuracy and reliability of diagnostic procedures performed with the affected systems.
The recall was reported through the Shanghai Municipal Drug Administration website and is overseen by the National Medical Products Administration (NMPA), the primary regulatory body in China for medical devices. The company proactively identified the defect and commenced the recall to ensure patient safety and product efficacy, adhering to the NMPA's regulatory framework for medical device post-market surveillance. Details concerning the specific product models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form," which accompanies the official notification. This recall highlights the manufacturer's responsibility to address potential safety and performance issues promptly, ensuring compliance with national medical device regulations.

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