Sinocare Inc. (300298.SZ) announced that it recently received a further important notice from its controlling subsidiary, Trividia Health Inc., regarding the TRUE METRIX® series of blood glucose monitoring systems, following an earlier label correction action. On February 6, 2026, Trividia initiated an Urgent Medical Device Correction involving updates to the labeling for all TRUE METRIX® series blood glucose monitoring systems. This correction pertained to the E-5 error code description in the user manual/system instructions and in online labels and help guides. On February 17, 2026, the U.S. Food and Drug Administration (FDA) concurrently issued an Early Alert to inform the public about this corrective measure. On March 12, 2026, the FDA classified this Urgent Medical Device Correction as a Class I medical device recall. The disposal measures published by the FDA are consistent with those described in the corrective notice issued by Trividia on February 6, 2026. Since the issuance of the corrective notice on February 6, 2026, Trividia has completed the updating and distribution of the revised labels and has been collaborating with the FDA to notify the public, ensuring users are aware of the updated instructions related to the E-5 error code. The purpose of this update is to emphasize that users must seek immediate medical attention if they receive an E-5 error code accompanied by symptoms of hyperglycemia. As of the disclosure date of the company's 2025 annual report (April 28, 2026), Trividia was still actively communicating with the FDA to determine the scope of any potential further actions. Following the principle of prudence, the company's management, based on best estimates, made a preliminary provision of $9.68 million (approximately RMB 68.05 million) in the 2025 fiscal year for costs associated with the recall. On May 1, 2026, based on an FDA Safety Communication regarding the E-5 error code, Trividia issued a new important notice concerning the aforementioned label correction. It advises patients currently using the TRUE METRIX® series blood glucose monitoring systems to consider switching to alternative blood glucose monitoring methods if possible. Otherwise, patients should continue using their TRUE METRIX® systems. Patients who continue using the system should follow the updated operating instructions if an E-5 error code appears. The risk is highest for diabetic patients reliant on intensive insulin therapy, sulfonylureas, or those requiring blood glucose monitoring due to frequent hypoglycemic or hyperglycemic events. These patients should consider switching to another method for blood glucose testing until the TRUE METRIX® series systems are fully updated. Trividia will provide a free TRUENESS® blood glucose monitoring system to users who request a replacement for testing their blood glucose. This recall does not involve any blood glucose monitoring products manufactured and sold by the company within China.
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