# China NMPA Product Recall - Cryostat

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/de052ec3-f070-405a-a5e5-23331a46680f/
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. On May 6, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recal

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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 current labels on cryostats do not include warnings about the use of flammable cryogenic sprays, necessitating corrective measures.
- Discovering Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Leica Microsystems (Shanghai) Trading Co., Ltd.
- Summary: On May 6, 2019, Leica Microsystems (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall for its Cryostat cryostat machines (Registration Certificate No.: 20161064). This action stemmed from post-market monitoring observations revealing that some users were employing flammable cryostat sprays within the product's freezer compartment. The critical issue identified was the absence of explicit warnings on the cryostat machine labels concerning the potential flammability and serious injury risks associated with these sprays. Overseen by the National Medical Products Administration (NMPA), this recall underscores a significant safety oversight. Leica Microsystems (Shanghai) Trading Co., Ltd. is required to implement corrective measures, primarily enhancing product labeling to clearly communicate the hazards of flammable cryostat sprays. This ensures user safety and adherence to regulatory requirements. Specific details regarding affected product models, specifications, and batches are provided in the comprehensive Medical Device Recall Event Report Form.

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