{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "100 Indigo Creek Dr",
      "reason_for_recall": "Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fisher\u0019s centrifuge module.  It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System.  Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.",
      "address_2": "",
      "product_quantity": "60 (US: 24; Foreign: 36)",
      "code_info": "Software Versions 3.6.1 and below;  Affected US Serial Numbers: 5GV6W2J,GBX395J, J2QKG25J, 2Z3YV1J, 3RHC23J, 4HX7S4J, 54FC01J, 5J4B45J, 736BM4J, 7KSC15J, J86PWC5J, 953209, 953221, 953266, 953270, B3ZHP2J, CXL941J, JFBX395J, FCM073J, FXCBG3J, JG7BFB5J, GWXQ52J, HJ5K84J, HPKG25J -- Affected Foreign Serial Numbers: DWXO52J, GWJZY4J, J16XQH4J, BGV6W2J, 17QP94J, 4SHPF4J, 1K5K84J, 37QP34J, H5PWC5J, J2V6LW4J, F6MXR3J, JT6LW4J, N0551107, F1150698, 46XQH4J, 2S5OP0J, CRKM82, J41BCY4J, J56T205J, BGV6W2J, 7YCF43J, 96XQHAJ, C1JNZ5J, C3JTP4J, D3JTP4J, 86T205J, 18BFB5J, 96PWC5J, 1LSSF5J, 4drj44j, 8W7WG3J, J953222, J953244, JCT20Q3J, HWJZY4J, 38769917923.",
      "center_classification_date": "20161022",
      "distribution_pattern": "Worldwide Distribution-(Nationwide) and foreign distribution to the following countries: Belgium, Bermuda, Canada, Chile, Denmark, France, Italy, Mexico, Norway, Portugal, Sweden, Taiwan and United Kingdom.",
      "state": "NY",
      "product_description": "enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code   952040-EG 6844097.    The VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-0300-2017",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "75167",
      "termination_date": "20180615",
      "more_code_info": "",
      "recall_initiation_date": "20160907",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}