# China NMPA Product Recall - Fully Automated Slide Pushing and Staining System / Blood Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/31a17f3a-d4ab-4e57-8705-ba80cce21962/
Source feed: China

> China NMPA product recall for Fully Automated Slide Pushing and Staining System / Blood Analyzer by Beckman Coulter, Inc. published December 07, 2016. Recall level: Level II. Beckman Coulter Trading (China) Co., Ltd., on behalf of Beckman Coulter, Inc., initiated a voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. has initiated a voluntary recall of its fully automated slide pushing and staining system and blood analyzer.
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2016-12-07
- Product Name: Fully Automated Slide Pushing and Staining System / Blood Analyzer
- Recall Level: Level II
- Recall Reason: Beckman Coulter has received and confirmed reports overseas regarding a methanol combustion incident involving a user-end DxH slide dyeing machine. The incident occurred solely within the slide dyeing machine module. The cause was attributed to a significant increase in the automatic refill frequency of the methanol tank within the module. The incident may also be related to a connected blood analyzer (all versions); the underlying cause is under further investigation.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter Trading (China) Co., Ltd., on behalf of Beckman Coulter, Inc., initiated a voluntary Class II recall for its Fully Automated Slide Pushing and Staining Systems and connected Blood Analyzers. This recall was reported on October 25, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 7, 2016. The recall was prompted by confirmed reports of methanol combustion incidents in user-end slide dyeing machines, identified as being caused by a significant increase in the automatic filling frequency of the methanol tank. The issue potentially extends to connected blood analyzers, with the full root cause still under investigation. Affected products include all versions globally, with 20 units sold or imported to China. As corrective actions, Beckman Coulter notified affected customers via letters and direct communication regarding the potential risks. The company also released an upgrade (MOD) for the slide dyeing system, which is being implemented for existing users, and plans a software correction for blood analyzer version 3.0.2.0. Beckman Coulter Trading (China) Co., Ltd. will provide monthly progress reports to the Shanghai Drug Administration.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-inc/7d99d114-1669-40c5-965a-4ba74c77a825/