# China NMPA Product Recall - Cryostat

Source: https://www.globalkeysolutions.net/records/china_product_recall/leica-microsystems-shanghai-trading-co-ltd/dc253339-d669-49ab-b5a2-c8638b6d5f85/
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 Class II voluntary recal

---

## 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 Class II voluntary recall of its Cryostat cryostat machines (Registration Certificate No.: 20180127). This action was taken under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall was prompted by post-market monitoring, which revealed a significant safety issue: users were found to be operating the cryostat machines with flammable cryostat sprays in the freezer compartment. The primary violation identified was the critical absence of appropriate safety warnings on the cryostat machine labels, which failed to caution against or prohibit the use of such flammable sprays. While the sprays themselves inherently pose a flammability risk, the deficiency in the machine's labeling created a potential for serious user injury. As a required action, Leica Microsystems (Shanghai) Trading Co., Ltd. is implementing improvement measures to ensure that clear warnings regarding the use of flammable cryostat sprays are prominently displayed on the cryostat machine labels, thereby mitigating the identified safety hazard and ensuring compliance with safety standards.

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