# 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/f5609648-e1b3-4646-a838-65d9e61d7a45/
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 for specific 

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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 for specific batches of its Fully Automated IHC and ISH Staining System. This action, reported on July 5, 2021, was prompted by a critical issue: a potential reading error in identifying loaded reagent kits under certain operating conditions. This malfunction could lead to inaccurate assay results, potentially affecting diagnostic outcomes. The National Medical Products Administration (NMPA) oversees this recall, with further details on affected models, specifications, and batches provided in the accompanying "Medical Device Recall Event Report Form" issued by the Shanghai Municipal Drug Administration. While specific inspection dates are not detailed in this public notice, the company's report indicates compliance with NMPA's regulatory framework for addressing product non-conformities. The required action for Leica Microsystems (Shanghai) Trading Co., Ltd. is to effectively manage this recall, ensuring all impacted systems are retrieved or remediated in accordance with regulatory guidelines to safeguard patient safety from the identified reading error.

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