# China NMPA Product Recall - GSP® Genetic Screening Processor Fully Automated Fluorescence Immunoassay Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/finland-wallac-oy/58db2762-1cd8-4664-b9e3-55e11ddc78b8/
Source feed: China

> China NMPA product recall for GSP® Genetic Screening Processor Fully Automated Fluorescence Immunoassay Analyzer by Finland Wallac Oy published April 06, 2017. Recall level: Level II. PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated fluorescence immunoassay analyzer.
- Company Name: Finland Wallac Oy
- Publication Date: 2017-04-06
- Product Name: GSP® Genetic Screening Processor Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level II
- Recall Reason: The recall involves defective sliding bearing shafts in some of the GSP instruments, which are at risk of corrosion when exposed to humid environments for extended periods. Corrosion of these shafts could impede the movement of the test microplate within the affected GSP module, potentially impacting test results.
- Discovering Company: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Finland Wallac Oy
- Summary: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall for its Fully Automated Fluorescence Immunoassay Analyzer (GSP
/ Genetic Screening Processor), as reported to the National Medical Products Administration (NMPA) on February 10, 2017, and publicly announced on April 6, 2017. The recall addresses a manufacturing defect in the sliding bearings of certain GSP instruments, which are susceptible to corrosion when exposed to high humidity over extended periods. While test results are unaffected prior to corrosion, the company identified potential risks if corrosion occurs, including the detachment of corrosion products into microplates, potentially impacting test accuracy, or causing mechanical issues that hinder smooth microplate movement, which could also affect results.

To mitigate these risks, PerkinElmer has outlined specific corrective actions. Service engineers will proactively replace the defective sliding bearing shafts in all affected units. Customers are instructed to maintain stringent quality control by rigorously monitoring test results with appropriate materials and only reporting patient results when established laboratory acceptance criteria are met. Furthermore, in the event of any mechanical malfunction concerning the blood smear dispenser, plate washer, or bulk reagent module, users must immediately cease operation and contact PerkinElmer's after-sales service. The instrument should not be used again until a service engineer has inspected or replaced the component. This global recall affects 13 units, with 7 not yet installed.

Company: https://www.globalkeysolutions.net/companies/finland-wallac-oy/62b2f7a6-435e-4b6e-ac72-c034613f3374/