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

PerkinElmer Medical Diagnostics Products (Shanghai) Co., Ltd., a responsible unit for products manufactured by Finland's Walac Oy, initiated a Class II voluntary recall for its Fully Automated Fluorescence Immunoassay Analyzer (GSP®). The recall was reported to the National Medical Products Administration (NMPA) on February 10, 2017, and published on March 17, 2017. The issue, affecting a global scope and 13 units imported into China, concerns a defect in certain sliding bearings within the GSP instruments. These bearings are susceptible to corrosion when exposed to humid environments for prolonged periods.

The primary concern is that corroded sliding bearing shafts could potentially detach corrosion products into microplates, thus impacting test results, or obstruct the movement of the test microplate within the GSP module, also affecting accuracy. Before corrosion, test results are unaffected. To mitigate this, PerkinElmer's corrective action involves after-sales service engineers replacing the defective sliding bearing shafts in all affected products.

Customers are required to strictly monitor test results using quality control materials according to kit instructions, reporting patient results only if quality control criteria are met. Furthermore, if a mechanical malfunction occurs in the blood smear dispenser, plate washer, or bulk reagent module, users must cease instrument operation immediately and contact a PerkinElmer after-sales service engineer for inspection or replacement before resuming use.