{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "140026",
      "product_res_number": "Z-0252-2016",
      "event_date_initiated": "2015-09-08",
      "event_date_posted": "2015-11-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-01-11",
      "res_event_number": "72160",
      "product_code": "NJT",
      "product_description": "Smooth Muscle Action (SMA) Immunohistochemistry reagent.  Catalog numbers: CME305A-0.1ml;  CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use.\n\nChemistry - IVD  Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.",
      "code_info": "Catalog numbers:  CME305A & CME305B: lots 110112, Expiry 11/2015;0 42213, expiry 4/2016; 101013, expiry 10/2016;  121813, expiry 12/2016; 070214, expiry 7/2017; 020215, expiry 2/2018.  Catalog number: PME305AA, lots 070513,  expiry 07/2016; 032114, expiry 3/2017, 030315, expiry 3/2018.",
      "firm_fei_number": "3004140393",
      "recalling_firm": "Biocare Medical, LLC",
      "address_1": "4040 Pike Ln",
      "city": "Concord",
      "state": "CA",
      "postal_code": "94520-1227",
      "additional_info_contact": "Scott Huntsman\n925-603-8033",
      "reason_for_recall": "Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA.",
      "root_cause_description": "Device Design",
      "action": "Biocare sent a Medical Device Recall Notification letter dated September 8, 2015, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately discontinue and dispose of all affected product.  Customers were asked to complete an return the enclosed Return Response Form.  Customer's accounts would be credited for all affected product.\nFor questions regarding this recall call 925-603-8033.",
      "product_quantity": "151 units",
      "distribution_pattern": "Worldwide Distribution - US including CO, FL, OH, SC, AZ, AL, FL, CT, NJ, CA, DC, KY, NC, TX, ID, MA, MD, OR, LA, PA,  KS, NY, UT, GA and Internationally to Spain, Sweden, Switzerland, Hungary, Italy, Germany, Turkey, Canada, India, Bolivia, Mexico, Indonesia and Australia.",
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        ],
        "device_name": "Immunohistochemistry Reagents And Kits",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.1860",
        "device_class": "1"
      }
    }
  ]
}