# China NMPA Product Recall - Antimicrobial susceptibility testing plates (Streptococcus antimicrobial susceptibility testing plates, Haemophilus influenzae/Streptococcus pneumoniae antimicrobial susceptibility testing plates)

Source: https://www.globalkeysolutions.net/records/china_product_recall/trek-diagnostic-systems-ltd/3c79c118-b064-460f-b9f5-47f5e1261f1d/
Source feed: China

> China NMPA product recall for Antimicrobial susceptibility testing plates (Streptococcus antimicrobial susceptibility testing plates, Haemophilus influenzae/Streptococcus pneumoniae antimicrobial susceptibility testing plates) by Trek Diagnostic Systems Ltd published August 04, 2023. Recall level: Level 3 Recall. Trek Diagnostic Systems Ltd., the manufacturer, has initiated a voluntary Class III recall of specif

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Trek Diagnostic Systems Ltd. is voluntarily recalling its antimicrobial susceptibility testing plates.
- Company Name: Trek Diagnostic Systems Ltd
- Publication Date: 2023-08-04
- Product Name: Antimicrobial susceptibility testing plates (Streptococcus antimicrobial susceptibility testing plates, Haemophilus influenzae/Streptococcus pneumoniae antimicrobial susceptibility testing plates)
- Recall Level: Level 3 Recall
- Recall Reason: Testing for Proteus strains with specific antibiotics may result in false-susceptibility results.
- Discovering Company: Thermo Fisher Scientific (China) Co., Ltd.
- Manufacturing Company: Trek Diagnostic Systems Ltd
- Summary: Trek Diagnostic Systems Ltd., the manufacturer, has initiated a voluntary Class III recall of specific antimicrobial susceptibility testing plates. This action was reported to the National Medical Products Administration (NMPA) by Thermo Fisher Scientific (China) Co., Ltd. on August 4, 2023. The recall addresses a critical issue: the potential for false susceptibility results when these plates are utilized with certain antibiotics, specifically during the testing of Proteus species. The identified defect could lead to incorrect diagnostic outcomes, potentially impacting patient treatment decisions.

The affected products include Streptococcus antibiotic testing plates (Imported Product No. 20182402254) and Haemophilus influenzae/Streptococcus pneumoniae antimicrobial susceptibility testing plates (National Medical Device Registration No. 20162400308). Under the oversight of the NMPA, the regulatory authority in China, Trek Diagnostic Systems Ltd. is implementing this recall to ensure product safety and reliability. Thermo Fisher Scientific (China) Co., Ltd., acting as the reporting entity, has provided detailed information regarding the models, specifications, and affected batches in a 'Recall Event Report Form.' This proactive measure aims to prevent the use of potentially faulty testing plates and uphold the accuracy of medical diagnostics.

Company: https://www.globalkeysolutions.net/companies/trek-diagnostic-systems-ltd/0e735506-78e0-484c-b3fd-d03dca12c517/