{
  "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": "2026-07-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Turku Varsinais-Suomi",
      "state": "N/A",
      "country": "Finland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99065",
      "recalling_firm": "WALLAC OY",
      "address_1": "Mustionkatu 6",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states and territories of AL, AR, AZ, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NJ, OR, PR, SC, TN, TX, VA, WV and the countries of Austria, Belgium, Egypt, France, Germany, Hong Kong, Iraq, Italy, Netherlands, Oman, Philippines, Saudi Arabia, Singapore, Spain, Thailand, United Arab Emirates, Vietnam.",
      "recall_number": "Z-2713-2026",
      "product_description": "GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic.      Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.",
      "product_quantity": "3,274 units",
      "reason_for_recall": "Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.",
      "recall_initiation_date": "20260518",
      "center_classification_date": "20260709",
      "report_date": "20260715",
      "code_info": "1. Product Code: 3303-001U. UDI-DI: 06438147321704. UDI-PI (PACKING LOT): (01)06438147321704(17)260531(10)763638 (1076363801); (01)06438147321704(17)260531(10)764085 (1076408501); (01)06438147321704(17)260531(10)765033 (1076503301); (01)06438147321704(17)260731(10)765231 (1076523101); (01)06438147321704(17)260731(10)765316 (1076531601); (01)06438147321704(17)261031(10)766420 (1076642001); (01)06438147321704(17)261031(10)766894 (1076689401); (01)06438147321704(17)261130(10)767873 (1076763801); (01)06438147321704(17)261130(10)768361 (1076836101); (01)06438147321704(17)261130(10)768703 (1076870301); (01)06438147321704(17)270228(10)769355 (1076935501); (01)06438147321704(17)270228(10)769542 (1076954201); (01)06438147321704(17)270228(10)769632 (1076963201); (01)06438147321704(17)270228(10)769671 (1076967101); (01)06438147321704(17)270228(10)769782 (1076978201); (01)06438147321704(17)270228(10)769871 (1076987101); (01)06438147321704(17)270228(10)769975 (1076997501); (01)06438147321704(17)270228(10)770078 (1077007801); (01)06438147321704(17)270228(10)770086 (1077008601); (01)06438147321704(17)270228(10)770351 (1077035101).   2. Product Code: 3303-0010. UDI-DI: 06438147311347. UDI-PI (PACKING LOT): (01)06438147311347(17)260531(10)763396 (1076339601);  (01)06438147311347(17)260531(10)763396 (1076339602);  (01)06438147311347(17)260531(10)764209 (1076420901);  (01)06438147311347(17)260531(10)764209 (1076420902);  (01)06438147311347(17)260731(10)765317 (1076531702);  (01)06438147311347(17)260731(10)7653177 (1076531703);  (01)06438147311347(17)261031(10)766378 (1076637801);  (01)06438147311347(17)261031(10)766943 (1076694301);  (01)06438147311347(17)261031(10)767323 (1076732301);  (01)06438147311347(17)261130(10)767955 (1076795501);  (01)06438147311347(17)261031(10)767956 (1076795601);  (01)06438147311347(17)261130(10)769214 (1076921401);  (01)06438147311347(17)261231(10)769967 (1076996701)."
    }
  ]
}