Reported Mar 18, 2026 · Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices.…
Trividia Health, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trividia Health, Inc. · 2400 Nw 55th Ct · Fort Lauderdale, FL · 33309-2672
Is this the product you have?
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices
- Description/ItemTRUE 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
- Lot codes and dates
- Device Item/UDI-DI
RE4H01P-40/21292006099RE4H01P-43/21292006105RE4212P-00/10840330705681RE4099P-40/21292014919RE4099P-43/21292008673RE4051P-00/20612479197217RE4068P-01/607415261097. Owner's Booklet
- or IFU Description/Part and RevisionTRUE METRIX PRO Owners Booklet/RE4TVHP03 Rev 56 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior
- Device serial numbersPrefix "TP" followed by a seven-digit numeric sequence
- Device Item/UDI-DI
- Amount recalled
- 1,001,534
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Trividia Health, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.