{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Fort Lauderdale",
      "state": "FL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98317",
      "recalling_firm": "Trividia Health, Inc.",
      "address_1": "2400 Nw 55th Ct",
      "address_2": "N/A",
      "postal_code": "33309-2672",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide including Puerto Rico and the countries of Mexico, United Kingdom, Jamaica, Trinidad & Tobago, and Australia.",
      "recall_number": "Z-1547-2026",
      "product_description": "Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices.  Description/Item:  Walgreens TRUE METRIX AIR Kit/REA4001-01,  Leader TRUE METRIX AIR Kit/REA4002-01,  CVS TRUE METRIX AIR Kit/REA4007-01,  GNP TRUE METRIX AIR Kit/REA4011-01,  Meijer TRUE METRIX AIR Kit/REA4019-01,  Publix TRUE METRIX AIR Kit/REA4020-01,  Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01,  HEB TRUE METRIX AIR Kit/REA4031-01,  SunmarkTRUE METRIX AIR Kit/REA4054-01,  Rite AidTRUE METRIX AIR Kit/REA4066-01,  Centerwell TRUE METRIX AIR Kit/REA4081-01,  HumanaTRUE METRIX AIR Meter Only/REA4081-40,  Centerwell TRUE METRIX AIR Starter Kit/REA4081-43,  Healthmart TRUE METRIX AIR  Kit/REA4089-01,  Relion TRUE METRIX AIR  Kit/REA4094-01,  Relion TRUE METRIX AIR  Kit/REA4094-01RX,  Kroger TRUE METRIX AIR  Kit/REA4203-01,  Foster and Thrive TRUE METRIX AIR  Kit/REA4211-01,  TRUE METRIX AIR  Kit/REA4H01-01,  TRUE METRIX AIR  NFRS Meter Only/REA4H01-40,  TRUE METRIX AIR  NFRS Starter Kit/REA4H01-43,  TRUE METRIX AIR Kit (mg/dL)/REA4i03-01,  TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02,  Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00,  TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11,  TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11,  TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12",
      "product_quantity": "3,678,026",
      "reason_for_recall": "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.",
      "recall_initiation_date": "20260206",
      "center_classification_date": "20260312",
      "report_date": "20260318",
      "code_info": "Device Item/UDI-DI:  REA4001-01/311917173894, REA4002-01/96295129267, REA4007-01/50428354766, REA4011-01/87701427398, REA4019-01/708820685659, REA4020-01/41415072787, REA4025-01/93351022784, REA4031-01/41220009169, REA4054-01/10939742445, REA4066-01/11822590051, REA4081-01/21292015015, REA4081-40/21292007164, REA4081-43/21292007584, REA4089-01/52569139042, REA4094-01/681131240154, REA4094-01RX/681131403214, REA4203-01/41260007354, REA4211-01/10939958617, REA4H01-01/21292007010, REA4H01-40/21292007447, REA4H01-43/21292007911,  International: REA4i03-01/N/A, REA4i03-02/N/A, REA4i04-00/21292012731, REA4i81-11/N/A, REA4i82-11/21292012212, REA4i82-12/21292009991.  Owner's Booklet or IFU Description/Part and Revision:  TRUE METRIX AIR Owner's Booklet/ REA4TVH03 Rev 57 and prior,  TRUE METRIX AIR Owner's Booklet (English)/ REA4TVH35 Rev 51 and prior,  TRUE METRIX AIR Owner's Booklet (Spanish)/ REA4TVH35S Rev 51 and prior,  Relion (Walmart) TRUE METRIX AIR Owners Booklet/ REA4RLN03 Rev 52 and prior,  Relion (Walmart) TRUE METRIX AIR Owner's Booklet - English/ REA4RLN35 Rev 52 and prior,  TRUE METRIX AIR Owner's Booklet International Trividia House Brand/ REA4ITV03 Rev 55 and prior,  TRUE METRIX AIR Owners Booklet for Trividia Health UK Limited/ REA4UKT03 Rev 55 and prior,  Trividia Health LATAM - TRUE METRIX AIR Owners Booklet/ REA4LAT03 Rev 51 and prior,  TRUE METRIX AIR Owners Booklet for Trividia Health Australia/ REA4AUT03 Rev 58 and prior.  Device serial numbers: Prefixes \"TB\" or \"TA\" followed by a seven-digit numeric sequence."
    }
  ]
}