{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219344",
      "product_res_number": "Z-1923-2026",
      "event_date_initiated": "2026-03-25",
      "event_date_posted": "2026-04-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98652",
      "product_code": "GRM",
      "product_description": "Oxoid Agglutinating Sera, Salmonella 9-0\nR30957301",
      "code_info": "UDI-DI 05056080500270\nlots 6172600, 6172741, 6171393, 6150168, 6107767, 3766399, 3766400, 3780497, 3719592, 3709358, 6266130, 6253410, 6260215, 6222350, 6233859, 6233858",
      "firm_fei_number": "3003750284",
      "recalling_firm": "Remel Europe Ltd.",
      "address_1": "Clipper Boulevard West Clipper Boulevard",
      "city": "West Ken Dartford",
      "country": "United Kingdom",
      "additional_info_contact": "Erica Knox\n800-2556730",
      "reason_for_recall": "Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm began notifying consignees on March 25, 2026 via letters titled \"Urgent: Medical Device Recall.\"\n\nLaboratory professionals are advised to review results and destroy any remaining inventory of affected lots. Affected lots should not be used for any clinical laboratory testing. Customers should complete and return the included acknowledgement form for replacement/credit to be processed. Notice should be passed on to all who need to be aware.\n\nFirm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.",
      "product_quantity": "117 US; 950 OUS",
      "distribution_pattern": "Worldwide - US Nationwide distribution to the states of AL, CA, FL, IA, IL, IN, MI, MN, MO, NC, NE, OH, SD, TX, WA.",
      "openfda": {
        "k_number": [
          "K961960",
          "K821338",
          "K910438",
          "K952134",
          "K960134",
          "K961967",
          "K960133",
          "K960126",
          "K960147",
          "K960152",
          "K960460",
          "K960142",
          "K960127",
          "K960335",
          "K960125",
          "K952288",
          "K960130",
          "K961950",
          "K960138",
          "K961949",
          "K960135",
          "K943400",
          "K960609",
          "K960160",
          "K951069",
          "K961966",
          "K961955",
          "K960463",
          "K960459",
          "K961958",
          "K960462",
          "K960161",
          "K961957",
          "K960124",
          "K960331",
          "K960603",
          "K960163",
          "K912791",
          "K961953",
          "K960137",
          "K960123",
          "K952133",
          "K961962",
          "K955222",
          "K960458",
          "K961948",
          "K960149",
          "K960136",
          "K960132",
          "K960461",
          "K960333",
          "K960610",
          "K961961",
          "K961954",
          "K960150",
          "K960129",
          "K961951",
          "K960131",
          "K960153",
          "K890146",
          "K960145",
          "K960465",
          "K961964",
          "K961956",
          "K961963",
          "K960162",
          "K870813",
          "K960140",
          "K961952"
        ],
        "device_name": "Antisera, All Groups, Salmonella Spp.",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3550",
        "device_class": "2",
        "registration_number": [
          "1050190",
          "8020667",
          "1119779",
          "3006440892",
          "9611882",
          "3005450604",
          "3003750284",
          "1025402",
          "8010096",
          "2027113",
          "3004569406",
          "8010383",
          "1649661",
          "3043196750"
        ],
        "fei_number": [
          "4247",
          "3006440892",
          "1119779",
          "1050190",
          "3001451797",
          "3005450604",
          "3003750284",
          "1025402",
          "1000354384",
          "2027113",
          "3004569406",
          "3006224287",
          "3002808078",
          "3043196750"
        ]
      }
    }
  ]
}