# China NMPA Product Recall - Navios flow cytometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/f4421935-dbe3-4e96-a3a4-c2f346722508/
Source feed: China

> China NMPA product recall for Navios flow cytometer by Beckman Coulter, Inc. published August 06, 2015. Recall level: Level III. Beckman Coulter Trading (China) Co., Ltd., acting on behalf of manufacturer Beckman Coulter Ireland,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Trading (China) Co., Ltd. voluntarily recalls flow cytometers
- Company Name: Beckman Coulter, Inc.
- Publication Date: 2015-08-06
- Product Name: Navios flow cytometer
- Recall Level: Level III
- Recall Reason: If the results and data graphs of the Navios flow cytometer software version 1.1 are not checked according to the label in the instruction manual, this event may produce erroneous results.
- Discovering Company: Beckman Coulter Trading (China) Co., Ltd.
- Manufacturing Company: Beckman Coulter, Inc.
- Summary: Beckman Coulter Trading (China) Co., Ltd., acting on behalf of manufacturer Beckman Coulter Ireland, Inc., initiated a voluntary Class III recall of its Navios Flow Cytometer on August 6, 2015. The recall was prompted by a detected defect in the embedded software, specifically version 1.1, which could produce inaccurate results if data graphs and outcomes were not meticulously verified against the instruction manual's guidelines. This issue impacts all versions of the Navios Flow Cytometer, with 14 units sold or imported into China. The recall was reported under the regulatory framework of the National Medical Products Administration (NMPA) of China, signifying compliance with Chinese medical device regulations for imported products. As a required corrective action, Beckman Coulter committed to upgrading the software on all affected devices to version 1.3 by June 1, 2016. Simultaneously, the company is updating the product's registration certificate to reflect these software enhancements, aiming to ensure product safety and reliability for its clinical medicine applications.

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