# China NMPA Product Recall - Sample preservation solution

Source: https://www.globalkeysolutions.net/records/china_product_recall/tripath-imaging-inc/6cd4ec58-5c27-4a4c-b000-bb0a91278073/
Source feed: China

> China NMPA product recall for Sample preservation solution by Tripath Imaging, Inc. published September 30, 2016. Recall level: III. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "Sample Preser

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. voluntarily recalls sample preservation solution
- Company Name: Tripath Imaging, Inc.
- Publication Date: 2016-09-30
- Product Name: Sample preservation solution
- Recall Level: III
- Recall Reason: A small number of bottle caps on the affected products may have cracks, which could lead to leakage of the preservation solution.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Tripath Imaging, Inc.
- Summary: BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "Sample Preservative Solution" in China, as detailed in an NMPA document published on September 30, 2016. The recall was reported on August 19, 2016, following the company's discovery that a limited number of bottle caps on certain batches of the alcohol-based solution, manufactured by Tripath Imaging, Inc., exhibited cracks. These cracks could lead to the leakage of the preservation solution, which is used for the transportation, preservation, and antibacterial treatment of gynecological samples. The affected product, identified by model/specification 490527 and various batch numbers, was produced or imported in quantities of 3,381,500 bottles globally, with 2,751,000 bottles sold within China. Under the regulatory oversight of the National Medical Products Administration (NMPA), the company is undertaking several corrective actions. These include issuing updated customer letters to inform them of expanded batch numbers, recalling and replacing all affected products from customers, and ensuring the proper destruction of the retrieved solutions. This proactive measure aims to mitigate potential risks associated with compromised product integrity and uphold public health standards.

Company: https://www.globalkeysolutions.net/companies/tripath-imaging-inc/b4b70100-0d13-4d05-87e4-e9be682399cb/