{
  "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": [
    {
      "country": "United States",
      "city": "San Diego",
      "address_1": "9975 Summers Ridge Rd",
      "reason_for_recall": "Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.",
      "address_2": "",
      "product_quantity": "280,710",
      "code_info": "Lot/Unit Codes:  DSD-765-011 (Alere PN 4012350099) \u0013 DOA2100709, DOA2110198, DOA2120093,  DOA3010031, DOA3010095, DOA3010096, DOA3010393, DOA3010566, DOA3020420.  DSD-765-011 (Alere PN 4080350099) \u0013 DOA2100672, DOA2120094, DOA2120095,  DOA2120158, DOA3010013, DOA3010064, DOA3010097, DOA3010394, DOA3010565,  DOA3020557.  DSF-765-031 (Alere PN 4584150099) \u0013 DOA2100438, DOA2100667, DOA2110073,  DOA2110315, DOA2120096, DOA2120738, DOA2120739, DOA3010003, DOA3010004,  DOA3010005, DOA3010199, DOA3010202, DOA3020182, DOA3020183.  DSF-765-011 (Alere PN 4582290164) \u0013 DOA2100250, DOA2110316 , DOA2110317 ,  DOA2120502, DOA2120503, DOA3010236.  DSF-765-011 (Alere PN 4028220211) \u0013 DOA2100614.    Expiration date, or Expected shelf life: 10/31/14 to 2/28/15.  Expected shelf life: 24 months.",
      "center_classification_date": "20140109",
      "distribution_pattern": "US Distribution: including states of: AL, CA, PA, and VA.",
      "state": "CA",
      "product_description": "Product Brand Name(s):   Innovacon Oral Fluid Drug Screen Device,   OrALert Oral Fluid Drug Screen Device,   OrALert Oral Fluid Drug Screen Device with BZO,   Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test.    Type of Packaging: 25 individually pouched test devices & collectors in a labeled  kit box.    The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an  immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid  specimen compete against their respective drug conjugates for binding sites on their specific antibody.",
      "report_date": "20140115",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Alere San Diego, Inc.",
      "recall_number": "Z-0653-2014",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "66870",
      "termination_date": "20140318",
      "more_code_info": "",
      "recall_initiation_date": "20130603",
      "postal_code": "92121-2997",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}