[pending] Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement
Pending LLM rewrite. Source: FDA_DEVICE Z-1546-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- 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 MET
- Manufacturer
- Trividia Health, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Device Item/UDI-DI: RE4H01P-40/21292006099
- RE4H01P-43/21292006105
- RE4212P-00/10840330705681
- RE4099P-40/21292014919
- RE4099P-43/21292008673
- RE4051P-00/20612479197217
- 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.
Distribution
Distributed nationwide across the United States.
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