# China NMPA Product Recall - Automatic dehydrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/9c03cbb6-daca-492b-af91-0783428262a7/
Source feed: China

> China NMPA product recall for Automatic dehydrator by Leica Microsystems (Shanghai) Trading Co., Ltd. published July 14, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced on July 14, 2017, that Leica Microsyst

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling its automated dehydrator.
- Company Name: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: Automatic dehydrator
- Recall Level: Level 3 Recall
- Recall Reason: The voltage indicated on the alarm connector on the back of the product is inconsistent with the Chinese instruction manual.
- Discovering Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on July 14, 2017, that Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall for its automated tissue dehydrator. The core issue driving this action was a discrepancy found between the voltage marking on the product's alarm connector and the voltage information detailed in the Chinese instruction manual. Such inconsistencies can pose potential risks regarding product usage, maintenance, or compliance, highlighting the importance of accurate product labeling and documentation. Under the oversight of the NMPA, Leica Microsystems (Shanghai) Trading Co., Ltd. reported this issue, leading to recall number 20150549. The company's required action involves the retrieval of affected units from the market. A Class III recall typically signifies that the product defect, while not likely to cause serious adverse health consequences, still violates NMPA regulations and necessitates corrective measures. Comprehensive details concerning the specific models, specifications, and affected production batches of the automated tissue dehydrator are provided in the "Medical Device Recall Event Report Form" associated with the NMPA's official notification. This action underscores the regulatory body's commitment to ensuring the safety and accuracy of medical devices available to the public.

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