Reported Mar 18, 2026 · Ongoing
Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring 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 measuring devices
- Description/ItemWalgreens 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 METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12
- Lot codes and dates
- Device Item/UDI-DI
RE4001-01/00311917166896RE4002-01/96295126600RE4002-40/96295126655RE4007-01SB/50428275283RE4011-00/87701426520RE4011-01/87701426254RE4019-01/713733069816RE4023-01/21292007256RE4025-01/93351018992RE4027-01/21292007065RE4031-01/41220001286RE4051-43/20612479197231RE4054-00/10939722447RE4054-01/10939719447RE4060-01/321130788669RE4061-01/41520147745RE4066-01/11822445610RE4078-40/21292007614RE4081-03/21292014797RE4087-01/77890394113RE4089-00/52569138557RE4089-01/52569138526RE4095-40/21292007041RE4097-01/725439988933RE4098-01/21292008901RE4099-40/21292014902RE4099-45/21292008697RE4202-43/21292007454RE4203-01/41260016028RE4209-01/36800234529RE4211-01/10939958693RE4H01-00/21292006082RE4H01-01/21292006051RE4H01-04/21292008895RE4H01-40/21292006068RE4H01-43/21292006075RE4H01-51/21292014940
- International
RE4i01-00/N/ARE4i01-01/N/ARE4i01-02/N/ARE4i03-02/N/ARE4i03-11/N/ARE4i05-00/N/ARE4i07-00/N/ARE4i23-00/21292010133RE4i29-11/N/ARE4i61-02/N/ARE4i61-02THI/N/ARE4i82-11/21292012205RE4i82-12/21292009977. Owner's Booklet
- or IFU Description/Part and RevisionTRUE METRIX Owner's Booklet/ RE4TVH03 Rev 56 and prior, TRUE METRIX Owner's Booklet (English)/ RE4TVH35 Rev 51 and prior, TRUE METRIX Owner's Booklet (Spanish)/ RE4TVH35S Rev 51 and prior, McKesson Med Surg TRUE METRIX Self Monitoring Owners Booklet/ RE4SUN03 Rev 55 and prior, McKesson Med Surg TRUE METRIX PRO Owners Booklet/ RE4SUNP03 Rev 56 and prior, TRUE METRIX Blood Glucose Monitoring System IFU Trividia House Brand/ RE4ITV16 Rev 53 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health UK Limited/RE4UKT16 Rev 55 and prior, Trividia Health LATAM - TRUE METRIX System IFU mg/dL/ RE4LAT16 Rev 50 and prior, TRUE METRIX System Instructions for Use (IFU) for Trividia Health Australia/ RE4AUT16 Rev 56 and prior
- Device serial numbersPrefix "T" followed by an eight-digit numeric sequence
- Device Item/UDI-DI
- Amount recalled
- 12,067,458
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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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