China NMPA Product Recall - Cleaning solution

Chongqing Tianhai Medical Equipment Co., Ltd. initiated a voluntary Class III recall for its Cleaning Solution (渝械备20150046号, MVIS-B 500mL/bottle, Batch Number: 20190415) following a supervision and spot check by a municipal bureau under the National Medical Products Administration (NMPA) framework. The recall, detailed in a report dated November 1, 2019, and published on November 26, 2019, stems from the discovery that the product's pH value did not meet its filed technical requirements.

This non-compliance affects 78 bottles of the specified batch, designed for use with the company's fully automated blood rheology analyzer to clean its reaction system. The identified pH deviation indicates a quality issue, necessitating corrective action to ensure product integrity and compliance.

In response to this finding, Chongqing Tianhai Medical Equipment Co., Ltd. outlined three required actions. First, all agents and end customers of the affected batch are to be notified immediately to cease shipping and using the product. Second, all non-conforming products are to be returned to the company. Finally, the recalled cleaning solutions will be destroyed as non-conforming items, ensuring they do not re-enter the supply chain. These measures aim to address the identified quality defect and uphold regulatory standards.