{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71609",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution: CT, TX, LA, ND, MI, NJ, OH, OK, PR, SC, and KY.",
      "recall_number": "Z-2330-2015",
      "product_description": "S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184    Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.",
      "product_quantity": "19 affected devices of lot 21450781 were distributed in the US.",
      "reason_for_recall": "The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.",
      "recall_initiation_date": "20150624",
      "center_classification_date": "20150805",
      "termination_date": "20160112",
      "report_date": "20150812",
      "code_info": "Catalog Number: 03260925184; Lot Numbers & Exp. Dates:     1. 21450781, Exp. 08/31/2016  2. 21450887, Exp. 08/31/2016  3. 21451391, Exp. 09/30/2016"
    }
  ]
}