China NMPA Product Recall - CD4 detection reagents

Beckman Coulter International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific CD4 test kits on April 19, 2021. This recall, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Municipal Drug Administration, was prompted by a significant labeling error. The company discovered that the bottle caps on certain batches of its CD4 test kits were incorrectly labeled "CD45" instead of the accurate "CD4." Although the labels on the individual vials and the overall reagent kits correctly displayed "CD4-FITC," this discrepancy on the bottle cap necessitated action to prevent potential user confusion and ensure product integrity.

To address this issue and maintain compliance with medical device regulations, Beckman Coulter is actively removing the mislabeled CD4 test kits, identified by Registration Certificate No.: ". This proactive measure aims to correct product inconsistencies and uphold the safety and reliability of its diagnostic products in the market. The Class III designation indicates that the mislabeling could cause temporary or medically reversible adverse health consequences, making this a critical corrective action to ensure accurate product identification and usage.