# China NMPA Product Recall - LC-MS/MS System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ab-sciex-pte-ltd/dc410af7-204c-44f9-b772-06796a9dc3c2/
Source feed: China

> China NMPA product recall for LC-MS/MS System by AB Sciex Pte. Ltd. published September 02, 2024. Recall level: Level 2 Recall. AB Sciex Pte. Ltd., in conjunction with Shanghai AB Sciex Analytical Instruments Trading Co., Ltd., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: AB Sciex Pte. Ltd. is voluntarily recalling its liquid chromatography-tandem mass spectrometry detection system.
- Company Name: AB Sciex Pte. Ltd.
- Publication Date: 2024-09-02
- Product Name: LC-MS/MS System
- Recall Level: Level 2 Recall
- Recall Reason: In extremely rare cases, such as solvent leakage at the tip of the ion source probe, there is a possibility that this could ultimately pose a risk to the customer's health or property.
- Discovering Company: Shanghai Aibocais Analytical Instruments Trading Co., Ltd.
- Manufacturing Company: AB Sciex Pte. Ltd.
- Summary: AB Sciex Pte. Ltd., in conjunction with Shanghai AB Sciex Analytical Instruments Trading Co., Ltd., initiated a voluntary Class II recall of its Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) System, as reported on September 2, 2024. This action was prompted by rare instances of solvent leakage at the top of the ion source probe, which could present potential health or property risks to users. The recall pertains to products distributed within China, operating under National Medical Device Registration Certificate No. 20232220176. While specific inspection dates were not provided, this proactive measure aligns with regulatory oversight from the National Medical Products Administration (NMPA). The company is taking necessary actions to mitigate the identified defect, with comprehensive details regarding specific models, specifications, and batches available in the Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/ab-sciex-pte-ltd/e0a44a55-3da6-4741-8ffb-272e1447c7a4/