China NMPA Product Recall - Fully automated chemiluminescence immunoassay analyzer

Sulling Diagnostics Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its fully automated chemiluminescence immunoassay analyzer (Registration Certificate No.: 20163402535). This action was publicly reported on April 10, 2019, with the Shanghai Food and Drug Administration issuing the pertinent recall notice. The primary issue prompting this recall was a product defect concerning the breakage of the POM (plastic) mixing rod, a critical accessory for the instrument. This identified problem could compromise the analyzer's operational integrity and overall performance.

Operating under the regulatory guidance of the National Medical Products Administration (NMPA) and the specific local oversight of the Shanghai Food and Drug Administration, Sulling Diagnostics undertook this recall to rectify the identified product deficiency. The company provided a "Medical Device Recall Event Report Form" containing detailed information on the affected models, specifications, and batch numbers. This voluntary recall highlights the company's dedication to ensuring product safety and adhering to medical device regulations, thereby safeguarding the reliability of diagnostic equipment in the market.