# 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/c1ab4b88-bfa6-4789-a386-b88a4a71b85d/
Source feed: China

> China NMPA product recall for GSP® Genetic Screening Processor Fully Automated Fluorescence Immunoassay Analyzer by Finland Wallac Oy published March 17, 2017. Recall level: Level II. PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II 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: 2017-03-17
- Product Name: GSP® Genetic Screening Processor Fully Automated Fluorescence Immunoassay Analyzer
- Recall Level: Level II
- Recall Reason: The recall involves GSP instruments with defects in certain sliding bearing shafts, which are at risk of corrosion if exposed to a humid environment for a long time.
- Discovering Company: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Finland Wallac Oy
- Summary: PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall on March 17, 2017, for its Fully Automated Fluorescence Immunoassay Analyzer, specifically models including the GSP®, Genetic Screening Processor. This action, reported to the National Medical Products Administration (NMPA), was prompted by the discovery of a defect in the sliding bearings of certain units, manufactured by Walac Oy, Finland. These bearings are susceptible to corrosion when exposed to humid environments over time. Such corrosion could potentially affect test results by causing debris to detach into microplates or impeding the smooth movement of the test microplate within the instrument.

To address this critical issue, PerkinElmer outlined a series of required actions. After-sales service engineers are tasked with replacing the defective sliding bearing shafts in all affected instruments. Prior to the replacement, customers are advised to rigorously monitor test results using quality control materials, as specified in the kit instructions, and only report patient results when these quality control criteria are met. Furthermore, in the event of any mechanical malfunction involving the blood smear dispenser, plate washer, or bulk reagent module, users must immediately discontinue using the instrument and contact PerkinElmer’s after-sales service. The instrument should only be returned to operational use after a certified service engineer has inspected it and confirmed the sliding bearing shaft's condition or completed its replacement.

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