{
  "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
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Raritan",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87028",
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "address_1": "1001 US Highway 202",
      "address_2": "",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia,\tIndia, Japan, Mexico, Singapore 609917, United Kingdom, \tFrance, Germany, Italy, Spain, Portugal, Poland, Russia, \tDenmark, Norway, Sweden, Belgium, The Netherlands.",
      "recall_number": "Z-0770-2021",
      "product_description": "VITROS Chemistry Products CKMB Slides:    (1)VITROS CKMB Slides (60 Slide cartridge)  Product Code:8058232     (2)VITROS CKMB Slides (18 Slide cartridge)  Product Code: 8001133    Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.",
      "product_quantity": "Total= 41,598 U.S. = 403 xU.S. = 41,195;  Extended: 25,775 units",
      "reason_for_recall": "VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference",
      "recall_initiation_date": "20201211",
      "center_classification_date": "20210105",
      "report_date": "20210113",
      "code_info": "INITIAL Communication: 11 December 2020, (Communication Ref. # CL2020-302) Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers)  Extended Recalls:  Recall Extension #1, for VITROS CKMB Slides, Coating 0245 (Communication Reference, CL2021-182) 18 June 2021  Recall Extension #2 for VITROS CKMB Slides, Coating 0246 (Communication Reference, CL2021-214)  18 August 2021  Recall Extension #3 for VITROS CKMB Slides, Coating 0248 (Communication Reference, CL2021-274) , 1 November 2021  Recall Extension #4 for VITROS CKMB Slides, Coating 0261 (Communication Reference, CL2023-244) , 27 October 2023  UDI:  (1) (10758750004294) (2) (10758750004201",
      "more_code_info": ""
    }
  ]
}