China NMPA Product Recall - Hemoglobin analyzer (Model 301)

Redormet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Hemoglobin Analyzer (Model 301) on October 20, 2020. This action, reported via the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), addresses a specific issue identified in the product manual. The primary concern is that numbers 5 and 6 in the manual are unclear, potentially leading to misinterpretation of important information. Although the company asserts that this clarity issue does not impact the analyzer's core function, a low risk of misreading the manual's content was acknowledged. The recall pertains to specific serial numbers of the Hemoglobin Analyzer (Model 301), which holds Registration Certificate No. 国械注进20162402695. A Class III recall indicates that the product defect is unlikely to cause adverse health consequences. Redormet Medical Equipment is taking proactive steps to manage this discrepancy and maintain product information accuracy for its users. Further details regarding affected models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."