# China NMPA Product Recall - Cryostat

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/bacee859-b1dd-44ef-9d5f-914949577a33/
Source feed: China

> China NMPA product recall for Cryostat by Leica Microsystems (Shanghai) Trading Co., Ltd. published May 06, 2019. Recall level: Level 2 Recall. Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its Cryosta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Leica Microsystems (Shanghai) Trading Co., Ltd. is voluntarily recalling its Cryostat cryostat microtome.
- Company Name: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Publication Date: 2019-05-06
- Product Name: Cryostat
- Recall Level: Level 2 Recall
- Recall Reason: The issue arose because the manufacturer discovered during post-market monitoring that some users were using flammable cryogenic sprays in the product's freezers. All flammable cryogenic sprays are potentially flammable and could cause serious injury. This risk should have been indicated on the labels of these sprays, but currently, the labels on the cryostats do not include warnings about the use of flammable cryogenic sprays.
- 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 II recall of its Cryostat cryostat machines, announced on May 6, 2019, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. This action followed post-market monitoring, which identified a significant safety concern: users were found to be applying flammable cryostat spray within the product's freezer compartment. The primary issue stemmed from an inadequacy in the product labeling. While all flammable cryostat sprays inherently carry a risk of flammability and potential for serious injury, the current labels on Leica Microsystems' cryostats did not provide explicit warnings regarding the use of such flammable sprays. This omission created an unforeseen hazard for users. As a result, Leica Microsystems (Shanghai) Trading Co., Ltd. proactively recalled its Cryostat cryostats, specifically those under Registration Certificate No.: 20150367. The "Medical Device Recall Event Report Form" contains detailed information regarding affected product models, specifications, and batches. This recall underscores the importance of comprehensive product labeling to ensure user safety and compliance with medical device regulations.

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