China NMPA Product Recall - Immunohistochemical preprocessing system

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.