{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "country": "United States",
      "city": "Grove City",
      "address_1": "3600 Gantz Rd",
      "reason_for_recall": "The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack of an adequate quiet zone can cause the bar code scanner to confuse the bar codes with text or graphics resulting in the scanner ignoring a valid symbol. This results in an error in reading the barcode: Error Code 2220 \u001cUnable to read barcode on reagent bottle\u001d. In some cases, the quiet zone is too short and an error in barcode reading occurs. The problem is intermittent and not all vials (6 vials are available per set) have been reported to fail. The only risk to patients or users is a delay in results. The company recommends (optional) that customers pre-screen the vials to identify affected products. Customers can contact the company for reimbursement of any affected products. The company has implemented barcode checks as a temporary solution and will replace the barcode printer on the production line for products beginning with lot B*01898.",
      "address_2": "",
      "product_quantity": "1012 units",
      "code_info": "Lot Numbers: IZ01893  Exp. 2019-07-31;                         I801890  Exp. 2019-11-30",
      "center_classification_date": "20191226",
      "distribution_pattern": "Nationwide  Foreign: Columbia, Dominic Republic, Ecuador",
      "state": "OH",
      "product_description": "AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706",
      "report_date": "20200101",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Tosoh Smd Inc",
      "recall_number": "Z-0745-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84299",
      "termination_date": "20200701",
      "more_code_info": "",
      "recall_initiation_date": "20191115",
      "postal_code": "43123-1895",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}