# China NMPA Product Recall - Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis System (WalkAway-96/40 plus)

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-trading-china-co-ltd/86911b02-2d31-4986-9200-b4e143f55286/
Source feed: China

> China NMPA product recall for Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis System (WalkAway-96/40 plus) by Beckman Coulter Trading (China) Co., Ltd. published March 13, 2019. Recall level: Level 3. On March 13, 2019, Beckman Coulter Trading (China) Co., Ltd. announced a voluntary Class III recall 

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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 microbial identification and antimicrobial susceptibility testing system.
- Company Name: Beckman Coulter Trading (China) Co., Ltd.
- Publication Date: 2019-03-13
- Product Name: Fully Automated Microbial Identification and Antimicrobial Susceptibility Analysis System (WalkAway-96/40 plus)
- Recall Level: Level 3
- Recall Reason: The fully automated microbial identification and antimicrobial susceptibility analysis system (WalkAway-96/40 plus) may reset and lose communication when a 2kV power surge occurs.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter Trading (China) Co., Ltd.
- Summary: On March 13, 2019, Beckman Coulter Trading (China) Co., Ltd. announced a voluntary Class III recall of its fully automated microbial identification and antimicrobial susceptibility analysis system, specifically the WalkAway-96/40 plus model. This action was initiated following an internal investigation by Beckman Coulter concerning electromagnetic compatibility (EMC) requirements. The investigation revealed a potential malfunction where the device might reset and lose communication when subjected to a 2kV power surge.
The recall falls under the oversight of the National Medical Products Administration (NMPA), as indicated by the NMPA Index No. JGXX-2019-10185 and a Medical Device Registration No. from the Shanghai Food and Drug Administration. The Class III designation signifies that the issue, while serious, is not expected to cause severe adverse health consequences.
As a required action, Beckman Coulter Trading (China) Co., Ltd. is undertaking this voluntary recall to address the identified susceptibility to power surges, ensuring product safety and performance standards. Further detailed information regarding the specific affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" attached to the official NMPA announcement. This proactive measure aims to mitigate potential risks associated with the device's operational stability.

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-trading-china-co-ltd/ba5d4d83-dfa7-4af5-bc20-f9174025eaad/