{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35016",
      "product_res_number": "Z-0047-05",
      "event_date_initiated": "2004-09-14",
      "event_date_posted": "2004-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-10-29",
      "res_event_number": "30017",
      "product_code": "GKA",
      "k_numbers": [
        "K840011"
      ],
      "product_description": "RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences  label, Kit Codes:  FR-9120 - 120 tests per kit;  FR-9400 - 360 tests per kit; and FR-9360 - 3600 tests per kit.",
      "code_info": "FR-9120 - Lot Number:  243309  FR-9360 - Lot Numbers:  213926, 213932, 213939, 213944, 220789, 220794, 220804, 220809, 220799, 220814, 220819, 220824, 220829, 220834, 220839, 220848, 220855, 220860, 220865, 220870, 220875, 220882, 220892, 220898, 228304, 228309, 228314, 228319, 228325, 228330, 228335, 228341, 228348, 228353, 228358, 228363, 228368, 228374, 228379, 228386, 228391, 228396, 229401, 228406, 234161, 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234210, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 238917, 234267, 234272, 234277, 238920, 238923, 238926, 238929, 238932, 238946, 238950, 238953, 238960, 238963, 242331, 242334, 242334.   FR-9400 - Lot Numbers:  213941,   220791, 220901, 220806, 220811, 220801, 220816, 220826, 220831, 220836, 220841, 220857, 220862, 220902, 220872, 220894, 220900, 228306, 228316, 228327, 228332, 228344, 228350, 228355, 228360, 228365, 228376, 228381, 228388, 228398, 228403, 228408, 2234192.",
      "firm_fei_number": "1522510",
      "recalling_firm": "PerkinElmer LAS Inc",
      "address_1": "3985 Eastern Rd",
      "city": "Norton",
      "state": "OH",
      "postal_code": "44203-6215",
      "additional_info_contact": "Cindy Lloyd\n330-825-4525",
      "reason_for_recall": "The product insert for the test kits is incorrect with regard to the acceptable storage temperature for the Agarose IEF gel component.  The kit and IEF gel labels indicate the correct storage temperature of 2-8 degrees C. The product insert incorrectly indicates that the product may be stored at 2-30 degrees C.",
      "root_cause_description": "Other",
      "action": "The firm contacted their consignees by letter dated 9/14/04.",
      "product_quantity": "All lots of test kits manufactured by the firm which have an active shelf life are subject to recall.",
      "distribution_pattern": "Nationwide (The product was distributed to firms located in AR, AZ, CA, CO,FL, GA, HI, IA, IL, IN, KS, KY,LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV )and worldwide (to 12 foreign accounts).",
      "openfda": {
        "k_number": [
          "K840011",
          "K050709",
          "K954048",
          "K112550",
          "K222635",
          "K955283",
          "K180762",
          "K040146",
          "K192931",
          "K052291",
          "K080911",
          "K811894",
          "K820573",
          "K822123",
          "K091283",
          "K112491",
          "K834595",
          "K082227",
          "K955355",
          "K051072",
          "K171664",
          "K232027",
          "K924813"
        ],
        "device_name": "Abnormal Hemoglobin Quantitation",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7415",
        "device_class": "2",
        "registration_number": [
          "2915274",
          "8023024",
          "8043909",
          "3005360469",
          "9610126",
          "1618982",
          "3003795116",
          "3032069621",
          "1931251",
          "1000487132"
        ],
        "fei_number": [
          "6387",
          "2915274",
          "3005670738",
          "3002806559",
          "3002808498",
          "1618982",
          "3003795116",
          "3032069621",
          "1931251",
          "1000487132"
        ]
      }
    }
  ]
}