Owner's Booklets and Instructions for Use that are used recall: Labeling Error
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter…
Why was Owner's Booklets and Instructions for Use that are used recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, Device serial numbers: Prefix "TP" followed by a seven-digit numeric sequence.
- Product
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter…
- Recalling firm
- Trividia Health, Inc.
- Quantity
- 1,001,534
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.
- Recall date
- March 18, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)