{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204627",
      "product_res_number": "Z-0603-2024",
      "event_date_initiated": "2023-10-31",
      "event_date_posted": "2023-12-21",
      "recall_status": "Open, Classified",
      "res_event_number": "93514",
      "product_code": "MYL",
      "pma_numbers": [
        "P150042"
      ],
      "product_description": "ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G",
      "code_info": "UDI: (01)00845533001724(17)240731(10)23030069\n(01)00845533001724(17)241231(10)23060238\n(01)00845533001748(17)241231(10)23060239;\nLot Numbers: 23030069\n23060238\n23060239",
      "firm_fei_number": "2242436",
      "recalling_firm": "Zeus Scientific, Inc.",
      "address_1": "199 Evans Way",
      "city": "Branchburg",
      "state": "NJ",
      "postal_code": "08876-4600",
      "additional_info_contact": "Alicia Barrett, MT (ASCP)\n908-243-4942",
      "reason_for_recall": "The organization completed a product improvement process to the conjugate found within the certain ELISA kits.  This modification was not reviewed and approved by FDA prior to its implementation.",
      "root_cause_description": "Device Design",
      "action": "An URGENT NOTICE Medical Device Recall was sent to customers on 10/31/23.\n\nActions to be Taken:\nPlease identify and discontinue use of the above product immediately. In addition, quarantine all unused product in preparation for returning it to ZEUS Scientific.\nIf you have used all the above product(s), please indicate as such on the attached Medical Device Recall Reply Form.\n\nIf you have any product with this lot number, please identify, discontinue use, and quarantine all unused product in preparation for returning it. In addition, please indicate the quantity of kits remaining in inventory on the attached Medical Device Recall Reply Form. Finally, if you have any kits in inventory, please contact ZEUS Scientific Technical Service at support@zeusscientific.com for return shipment instructions.\n\nIf you have questions about the recall or would like to notify our organization of an adverse event, please contact us at regulatory@zeusscientific.com . Additionally, please contact FDA MedWatch in the case you will need to report an adverse event, using the toll-free information line, 1-888-INFO-FDA (1-888-463-6332) and press 2 to report into MedWatch or for instructions.\n\nOur regulatory policy requires signed verification of this notice on the Medical Device Recall Reply Form. Please sign in the space provided and return that page via Fax or email to regulatory@zeusscientific.com.",
      "product_quantity": "293 kits",
      "distribution_pattern": "US States: CA, MA, MI, NJ, NY, TN, UT.",
      "openfda": {
        "pma_number": [
          "P970054",
          "P150045",
          "P220034"
        ],
        "device_name": "Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "9610240",
          "2242436",
          "2023365"
        ],
        "fei_number": [
          "2023365",
          "2242436",
          "3002808212"
        ]
      }
    }
  ]
}