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 TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01.
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 TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified April 6, 2026.
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Check if you qualifyKey facts
- Date announced
- March 18, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
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 TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
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.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Trividia health, inc.
- Category
- medical
- Source agency
- FDA
- Announced
- March 18, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
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,
| # | Model |
|---|---|
| 1 | 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, |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- March 18, 2026
- Last reviewed by RecallRadar
- April 6, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists 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,.
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the trividia health, inc. recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1546-2026&limit=1
Keep browsing with these internal hubs: trividia health, inc. recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- March 18, 2026
- Source agency
- FDA
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