# China NMPA Product Recall - Immunohistochemical preprocessing system

Source: https://www.globalkeysolutions.net/records/china_product_recall/danko-ag/2ea324cb-18af-420e-9062-47340c4ecd7b/
Source feed: China

> China NMPA product recall for Immunohistochemical preprocessing system by Danko AG published December 29, 2018. Recall level: Level 3. Danko AG, a Danish manufacturer, initiated a voluntary Level III recall of its Immunohistochemical P

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Danco AG of Denmark voluntarily recalls its immunohistochemistry pretreatment system.
- Company Name: Danko AG
- Publication Date: 2018-12-29
- Product Name: Immunohistochemical preprocessing system
- Recall Level: Level 3
- Recall Reason: Agilent has confirmed that several of the aforementioned instruments were shipped to China without Chinese labels, thus failing to comply with the National Medical Products Administration (NMPA) regulations regarding device labeling. Please note that the performance of the devices will not be affected; only PTLink devices with verified serial numbers are affected. All manufactured and distributed products have been checked for correct labeling, and corrective actions to replace the incorrectly labeled devices are underway.
- Discovering Company: Agilent Technologies (China) Co., Ltd.
- Manufacturing Company: Danko AG
- Summary: Danko AG, a Danish manufacturer, initiated a voluntary Level III recall of its Immunohistochemical Pretreatment System (PT Link PT200, National Approval Number 20162040). Reported by Agilent Technologies (China) Co., Ltd. on December 24, 2018, and published by the National Medical Products Administration (NMPA) on December 29, 2018, the recall affects 50 specific units. The primary violation involved these instruments being shipped to China without the mandatory Chinese labels, failing to comply with NMPA's regulatory requirements for medical device labeling. It was confirmed that this labeling issue does not impact the devices' performance or pose any potential harm or safety risk to patients or users. As a required action, Agilent Field Service Engineering is contacting customers to affix the correct Chinese labels on-site. The company is also ensuring all manufactured and distributed products are checked for proper labeling, with corrective actions underway to rectify any labeling discrepancies.

Company: https://www.globalkeysolutions.net/companies/danko-ag/260455cc-116c-409b-b2f4-aff9a97c3808/