{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "186186",
      "product_res_number": "Z-1424-2021",
      "event_date_initiated": "2021-03-10",
      "event_date_created": "2021-04-13",
      "recall_status": "Open, Classified",
      "res_event_number": "87495",
      "product_code": "JSO",
      "k_numbers": [
        "K892928"
      ],
      "product_description": "Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033\n\nRemel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.",
      "code_info": "Lot Numbers:  201334 Exp. 2021-01-21, 210892 Exp. 2021-02-03, 217048 Exp. 2021-02-10",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "Technical Services\n800-255-6730",
      "reason_for_recall": "When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm, ThermoFisher Scientific, sent an \"Medical Device Field Action Recall\" letter dated 3/10/2021 to its consignees on 03/10/2021.  The letter described the product, problem and actions to be taken.  The consignees were instructed to do the following:\n\nReview the reported test results should be determined by the appropriate technical expert. Please keep this notification on file.\n\nThis notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.\n\nYou should complete the accompany  Acknowledgment Form upon receipt and \nreturn to MBD.vigilance@thermofisher.com.\n\nIf you have any further questions, contact Director, Quality Assurance and Regulatory Affairs at  913-895-4077 or email:  gary.klaassen@thermofisher.com  Copy to: Beverly Marsh - beverly.marsh@thermofisher.com.",
      "product_quantity": "408 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K941444",
          "K770441",
          "K923892",
          "K181092",
          "K092767",
          "K092407",
          "K952595",
          "K151688",
          "K964560",
          "K951754",
          "K081212",
          "K892928",
          "K162076",
          "K962744",
          "K932879",
          "K160512",
          "K162620",
          "K881567",
          "K903425",
          "K091024",
          "K102922",
          "K122187",
          "K894848",
          "K941443",
          "K811513",
          "K092819",
          "K972359",
          "K944554",
          "K070361",
          "K881568",
          "K103684",
          "K190553",
          "K171061",
          "K073027",
          "K894216",
          "K091025",
          "K042812",
          "K932882",
          "K100589",
          "K945569"
        ],
        "registration_number": [
          "3009547954",
          "3013394941",
          "3035708936",
          "8023060",
          "2022807",
          "3009307598",
          "1111096",
          "1924669",
          "9615755",
          "1119779",
          "8010096"
        ],
        "fei_number": [
          "3009547954",
          "3013394941",
          "3035708936",
          "2022807",
          "1111096",
          "3009307598",
          "1924669",
          "3007808629",
          "1119779",
          "3003992026",
          "3006224287"
        ],
        "device_name": "Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1700",
        "device_class": "2"
      }
    }
  ]
}