| | Class 1 Device Recall TRUE METRIX GO SelfMonitoring Blood Glucose System |  |
| Date Initiated by Firm | February 06, 2026 |
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| Date Posted | March 12, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1548-2026 |
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| Recall Event ID |
98317 |
| 510(K)Number | K143548 |
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| Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
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| Product | 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 |
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| Code Information |
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. |
| FEI Number |
1000113657
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Recalling Firm/
Manufacturer |
Trividia Health, Inc.
3230 W Prospect Rd
Fort Lauderdale FL 33309-2592
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| For Additional Information Contact | Annmarie Ramos
800-342-7226 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Software design |
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| Action | On 2/6/2026, press was issued and correction notices were emailed to customers.
The E-5 Error Code in the Messages section of the Owner's Booklets/System Instructions for Use emphasizes that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. Firm will notify users of additional mitigation strategies as needed.
Customers: notify your customers immediately of the correction and to include the letter in their notification, and to ask that they notify their customers or facilities if they have further distributed the Products.
Retail pharmacies: post the notice in areas where the Products are sold to notify patients.
Multiple Patient Facilities: post the notice provided in areas where the Products are stored within your facility to notify personnel of this labeling correction.
People with Diabetes are asked to follow the updated E-5 error code instructions in the notice or visit www.trividiahealth.com for links to the updated Owner's Booklets and help resources.
Complete and return the acknowledgement form via email to trividia0126CS@trividiahealth.com
If you have any questions, please call Customer Care Department toll-free at 1-888-835-2723 Monday-Friday 8AM-8PM EST (excluding holidays) or e-mail trividia0126CC@trividiahealth.com or visit www.trividiahealth.com/E-5productnotice , which has links to Owner's Booklets, correction notice, and press. |
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| Quantity in Commerce | 1,407,465 |
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| Distribution | Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = NBW
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