# China NMPA Product Recall - Fully automated slide preparation and staining system / blood analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-inc/e5526121-944d-4393-8b2b-154d9aad79f4/
Source feed: China

> China NMPA product recall for Fully automated slide preparation and staining system / blood analyzer by Beckman Coulter, Inc. published January 03, 2017. Recall level: Level II. Beckman Coulter Trading (China) Co., Ltd. initiated a Class II voluntary recall on October 25, 2016,

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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: 2017-01-03
- Product Name: Fully automated slide preparation and staining system / blood analyzer
- Recall Level: Level II
- Recall Reason: Beckman Coulter has received and confirmed reports overseas regarding a user-end DxH slide dyeing solution (methanol) combustion incident. This incident occurred only within the slide dyeing module. The event was caused by a significant increase in the frequency of volatile charging of the cresol tank within the module, and may also be related to a connected blood analyzer (all versions). The root 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. initiated a Class II voluntary recall on October 25, 2016, affecting its Fully Automated Slide Pushing and Staining System and Blood Analyzer products. This action was prompted by overseas reports of dye solution (methanol) combustion occurring within the slide dyeing machine module at user sites. The incident, potentially linked to its connected blood analyzer, was attributed to a significant increase in the frequency of automatic charging of the cresol pool. The root cause remains under investigation.

Under the oversight of the National Medical Products Administration (NMPA), Beckman Coulter implemented several corrective measures. The company promptly informed affected customers about the potential risks and provided relevant information. A critical upgrade has been released for the fully automated slide preparation and staining system, with existing users undergoing these updates. Additionally, the issue has been addressed in the blood analyzer with the release of version 3.0.2.0. Beckman Coulter Trading (China) Co., Ltd. is committed to reporting monthly progress updates to the Shanghai Drug Administration to ensure effective resolution.

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