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U.S. Department of Health and Human Services

Class 1 Device Recall TRUE METRIX PRO Professional Monitoring Blood Glucose System

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 Class 1 Device Recall TRUE METRIX PRO Professional Monitoring Blood Glucose Systemsee related information
Date Initiated by FirmFebruary 06, 2026
Date PostedMarch 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1546-2026
Recall Event ID 98317
510(K)NumberK140100 
Product Classification System, test, blood glucose, over the counter - Product Code NBW
ProductOwner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
Code Information Device Item/UDI-DI: RE4H01P-40/21292006099, RE4H01P-43/21292006105, RE4212P-00/10840330705681, RE4099P-40/21292014919, RE4099P-43/21292008673, RE4051P-00/20612479197217, RE4068P-01/607415261097. Owner's Booklet or IFU Description/Part and Revision: TRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior,
FEI Number 1000113657
Recalling Firm/
Manufacturer		 Trividia Health, Inc.
3230 W Prospect Rd
Fort Lauderdale FL 33309-2592
For Additional Information ContactAnnmarie Ramos
800-342-7226
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.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce1,001,534
DistributionWorldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = NBW
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