Sinocare Inc. (300298.SZ): Subsidiary product recall action for the TRUE METRIX series of blood glucose monitoring systems.
Sanuo Bio announced that the company recently received an important notification from its controlling subsidiary Trividia Health Inc. ("Trividia") regarding the TRUE METRIX series of blood glucose monitoring system products following the label correction measures.
Sinocare Inc. (300298.SZ) announcement, the company recently received a further important notification from its subsidiary Trividia Health Inc. ("Trividia") regarding the TRUE METRIX series blood glucose monitoring system products following a labeling correction measure.
On February 6, 2026, the company's subsidiary Trividia initiated an "Urgent Medical Device Correction," involving the correction of all TRUE METRIX series blood glucose monitoring system labels. This correction involves correcting the E-5 error code in the "Message" section of the user manual/system instructions and online labels and help guides. On February 17, 2026, the Food and Drug Administration (FDA) simultaneously issued an Early Alert to inform the public of this correction measure. On March 12, 2026, the FDA categorized this "Urgent Medical Device Correction" as a Class I medical device recall, and the disposal measures announced were consistent with those stated in the correction notice released by Trividia on February 6, 2026.
Since the release of the correction notice on February 6, 2026, Trividia has completed the updating and release of labels and continues to work with the FDA to inform the public to ensure users are aware of the latest instructions regarding the E-5 error code. The purpose of this update is to emphasize that users must seek medical attention immediately when receiving the E-5 error code accompanied by symptoms of high blood sugar. As of the disclosure date of the company's 2025 annual report (April 28, 2026), Trividia is still actively communicating with the FDA to determine the scope of potential further measures. The company's management follows the principle of prudence and has provisionally estimated a cost of $9.68 million (approximately RMB 68.05 million) related to the recall in the 2025 fiscal year.
On May 1, 2026, based on the FDA's Safety Communication related to the E-5 error code, Trividia issued a new important notification regarding the labeling correction mentioned above, advising patients using the TRUE METRIX series blood glucose monitoring system to consider switching to alternative methods for monitoring their blood sugar if possible; otherwise, patients should continue using their TRUE METRIX series blood glucose monitoring system. For patients continuing to use the system, they should follow the updated operating instructions when the E-5 error code occurs. Diabetic patients who rely on intensified insulin therapy, sulfonylureas, or who require blood glucose monitoring due to frequent occurrences of low or high blood sugar events are at the highest risk. Before the TRUE METRIX series blood glucose monitoring system is updated, consideration should be given to switching to other methods to monitor blood sugar. Trividia will provide a free set of Trividia's TRUENESS blood glucose monitoring system for blood glucose testing to users who request a replacement.
This recall does not involve any blood glucose monitoring products manufactured and sold by the company in China.
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