Trividia Health Class I Device Recall

FDA: Device Recalls Class I

Filed March 18th, 2026

Detected March 23rd, 2026

Summary

The FDA has issued a Class I device recall for Trividia Health's owner booklets and instructions for use associated with various TRUE METRIX GO blood glucose measuring devices. The recall is due to inadequate labeling regarding the E-5 error code, which could lead to delayed treatment for users experiencing high blood glucose levels.

View original document View source feed page

What changed

The U.S. Food and Drug Administration (FDA) has classified a recall initiated by Trividia Health, Inc. as a Class I recall, the most serious category. The recall pertains to owner booklets and instructions for use for several TRUE METRIX GO blood glucose measuring devices, including kits distributed under various retail brands like Walgreens, CVS, and Meijer. The issue stems from labeling that does not adequately inform users about the E-5 error code, potentially causing users to delay seeking medical attention for dangerously high blood glucose levels.

This recall impacts approximately 1.4 million units distributed worldwide. Regulated entities, particularly those involved in the distribution or use of these devices, should be aware of the recall status and the specific product descriptions. While this is a voluntary recall initiated by the firm, the FDA's classification highlights a significant product safety concern. Compliance officers should ensure that any affected devices are properly managed according to recall procedures and that communication with healthcare providers and patients is clear regarding the labeling deficiency and potential health risks.

What to do next

Review Trividia Health's recall notice for TRUE METRIX GO devices.
Ensure affected product inventory is managed according to recall procedures.
Communicate potential risks to relevant stakeholders, including healthcare providers and patients.

Source document (simplified)

json { "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Fort Lauderdale", "state": "FL", "country": "United States", "classification": "Class I", "openfda": { }, "product_type": "Devices", "event_id": "98317", "recalling_firm": "Trividia Health, Inc.", "address_1": "3230 W Prospect Rd", "address_2": "N/A", "postal_code": "33309-2592", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.", "recall_number": "Z-1548-2026", "product_description": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK", "product_quantity": "1,407,465", "reason_for_recall": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.", "recall_initiation_date": "20260206", "center_classification_date": "20260312", "report_date": "20260318", "code_info": "Device Item/UDI-DI: RF4001-01BK/311917178691, RF4007-01/50428560402, RF4019-01/708820721098, RF4023-01/21292009335, RF4031-01/41220136131, RF4048-01/75450843576, RF4066-01/11822002783, RF4209-01/36800234567, RF4H01-01BK/21292006112, RF4H01-40/21292009793. International: RF4i29-11BK/N/A, RF4i81-11BK/N/A, RF4i82-11BK/21292012229, RF4i82-12BK/21292009984. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX GO Owner's Booklet/ RF4TVH03 Rev 57 and prior, TRUE METRIX GO Owner's Booklet (English)/RF4TVH35 Rev 51 and prior, TRUE METRIX GO Owner's Booklet (Spanish)/RF4TVH35S Rev 51 and prior, TRUE METRIX GO Blood Glucose Monitoring System IFU Trividia House Brand/ RF4ITV16 Rev 55 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health UK Limited/ RF4UKT16 Rev 56 and prior, Trividia Health LATAM- TRUE METRIX GO System IFU/ RF4LAT16 Rev 51 and prior, TRUE METRIX GO System Instructions for Use (IFU) for Trividia Health Australia/ RF4AUT16 Rev 57 and prior," } ] }