{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 20
    }
  },
  "results": [
    {
      "cfres_id": "184105",
      "product_res_number": "Z-0441-2021",
      "event_date_initiated": "2020-10-06",
      "event_date_created": "2020-11-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-05-28",
      "res_event_number": "86586",
      "product_code": "PQZ",
      "k_numbers": [
        "K170586"
      ],
      "product_description": "Strep B Carrot Broth One-Step, Ref. Z40,  UDI: 00819398026499",
      "code_info": "Lot # 465086",
      "firm_fei_number": "2022807",
      "recalling_firm": "Hardy Diagnostics",
      "address_1": "1430 W McCoy Ln",
      "city": "Santa Maria",
      "state": "CA",
      "postal_code": "93455-1005",
      "additional_info_contact": "Hardy Diagnostic Technical Services\n800-266-2222 Ext. 2",
      "reason_for_recall": "Streptococcus culture medium contains an incorrect expiration date. The culture medium  outer box labeling contains an expiration date of  2021-11-10 instead of the correct expiration date of 2020-11-10",
      "root_cause_description": "Employee error",
      "action": "Hardy Diagnostic sent a \"Urgent: Recall Notification\"  on 9/30/2020  and sent a follow-up letter 10/06/2020 containing additional information. In addition to notifying  consignees about the recall, the firm asked consignees to take the following actions:\n\n1. Please respond to the notification within 10 business days of receipt of the letter, either through mail or email.\n\n2. To respond by email, please scan and send the completed inventory reconciliation form (FORM-2023C) to TechService@HardyDiagnostics.com. After a response is received, new labels with the correct expiration date will be sent to you for product that has not yet been used.\n\n3. Upon expiration of the product, on November 10, 2020, discard any remaining stock. This product should be destroyed according to local regulation as non-hazardous waste if un-inoculated or as medical waste if inoculated.\n\n4. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. Additionally, please take the following actions:\n - Notify any and all employees who may use the product.\n- If the product was further distributed, notify the consignees the product was distributed to.\n\n5. Any Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), by regular mail or by fax.\n\n6. Please feel free to contact Technical Services if you have additional questions about this notification through email (listed above) or through phone call at (800) 266-2222, option 2, Monday through Friday, 8:00 AM to 5:00 PM, Pacific Time.",
      "product_quantity": "8,620 units",
      "distribution_pattern": "US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN,  NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam",
      "openfda": {
        "k_number": [
          "K170586",
          "K163042",
          "K173903",
          "K170481"
        ],
        "registration_number": [
          "9615755",
          "2022807",
          "3009547954"
        ],
        "fei_number": [
          "2022807",
          "3009547954",
          "3007808629"
        ],
        "device_name": "Gbs Culture Media, Selective And Differential",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2360",
        "device_class": "1"
      }
    }
  ]
}