Device recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.…
Class I FDA enforcement event 98317. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Trividia Health, Inc. started this device recall on 6 Feb 2026. The firm address in the FDA record is in Fort Lauderdale, FL. FDA put the recall in Class I. FDA event 98317 has 4 product records. The first FDA enforcement report date is 18 Mar 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
Recalling firm
Trividia Health, Inc., Fort Lauderdale, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1545-2026 | Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE… | 12,067,458 | Class I | Ongoing | 18 Mar 2026 |
| Z-1546-2026 | Owner'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… | 1,001,534 | Class I | Ongoing | 18 Mar 2026 |
| Z-1547-2026 | Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01,… | 3,678,026 | Class I | Ongoing | 18 Mar 2026 |
| Z-1548-2026 | 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,… | 1,407,465 | Class I | Ongoing | 18 Mar 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class I
- 12%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Oct 2025 | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. | Device | Class II | 1 |
| 20 Apr 2020 | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucos | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1545-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 98317. https://recallregister.com/fda/i/98317/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
- What quantity of product is in FDA event 98317?
- The event has 4 product records. The first record gives this quantity:
12,067,458
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 12% of the 572 device events that started in 2026 are in Class I.