The Food and Drug Administration (FDA) has classified a recall of Trividia Health's TRUE METRIX PRO Meter Only/RE4H01P-40 and TRUE METRIX PRO Starter Kit as a Class I recall (Z-1546-2026). The recall is due to inadequate labeling in the owner's booklets and instructions for use. Specifically, the system labeling did not provide sufficient directions for lay users to act on the E-5 error code, which could represent a serious issue with the blood glucose measurement device.

This recall affects worldwide distribution, including the United States, Puerto Rico, Mexico, the United Kingdom, Jamaica, Trinidad & Tobago, and Australia. Healthcare providers and medical device makers should be aware of this recall and ensure any affected products are handled appropriately according to FDA guidelines. While no specific compliance deadline is mentioned, prompt action is expected given the Class I classification, indicating a reasonable probability of serious adverse health consequences or death.