{
  "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": "Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA)  Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers.  To date, no occurrences of this issue have been observed on Ortho\u0019s enGen(TM) Systems.  Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.)  The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.)  At least two additional sample tubes (Samples B and C) are waiting to be aspirated in the Bypass module queue, and (3.) A Radio Frequency Identification (RFID)  Tag  Read failure occurs on the Sample A carrier, and  (4.) The VITROS System is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- If the software anomaly occurs and the issue is present, the Sample ID in the INOUT communication device software queue becomes asynchronous with the actual Sample ID physical queue, and the VITROS assay result will be reported for the wrong Sample ID.  All subsequent samples will have miss-associated results until the Bypass module is reset or the queue is empty. --- This issue could potentially miss-associate a sample/patient ID with a test result of a different sample.  Depending on the test involved, patient\u0019s health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention.  To date, no patient harm was reported related to this product issue.",
      "address_2": "",
      "product_quantity": "US: 33 units; OUS: 43 units",
      "code_info": "US Serial Numbers/J Numbers: B3ZHP2J/JB3ZHP2J;  736BM4J/J736BM4J; 953289/J953289;  953252/J953252;  HJ5K84J/JHJ5K84J; FCM073J/JFCM073J;  HPKG25J/JHPKG25J;  GWXQ52J/JGWXQ52J; GBX395J/GBX395J;  JFBX395J/JFBX395J;  FXCBG3J/JFXCBG3J; 3RHC23J/J3RHC23J;  JG7BFB5J/JG7BFB5J;  953270/J953270; 953221/J953221;  54FC01J/J54FC01J;  953209/J953209;  5J4B45J/J5J4B45J; 5LQ6Q2J/ J5LQ6Q2J;  2Z3YV1J/J2Z3YV1J;  FRKMB2J/JFRKMB2J; 5GV6W2J/5GV6W2J;  7KSC15J/J7KSC15J; 953276/J953276;  J2QKG25J/J2QKG25J;  DK2BG3J/JDK2BG3J;  953266/J953266;  J86PWC5J/ J86PWC5J;  JXBQW4J/JJXBQW4J;  CXL941J/JCXL941J;  J953224/J953224; 36PWC5J/J36PWC5J;  4HX7S4J/J4HX7S4J --- Foreign Serial Numbers/J #s:  CRKM82/J31265;  2S5OP0J/J31067;  C4Z655J/ J31421;  6VR7K4J/J31401;    90JYS22/J31350;  HWJZY4J/JHWJZY4J;  J3J4B45J/J3J4B45J;  JCT20Q3J/JCT20Q3J;  J953234/J953234;  J41BCY4J/J41BCY4J;  J953244/J953244;  J1HX7S4J/ J1HX7S4J;  J16XQH4J/J16XQH4J;  GWJZY4J/ GWJZY4J;  DWXO52J/DWXO52J;  17QP94J/J20022;  BGV6W2J/ J20003;  H5PWC5J/J271371;  2LSSF5J/J271377;  1K5K84J/ J271264;  8W7WG3J/J85206;  96XQHAJ/ J7023645; 1LSSF5J/J7025050; 86T205J/ J7024893;  C3JTP4J/J7023847;  D3JTP4J/J7023874;  C1JNZ5J/J7023730;   7DRJ44J/J7023728;  7YCF43J/J7023435;  18BFB5J/J7025017;  J953222/J953222;  J2V6LW4J/J2V6LW4J;  J56T205J/J56T205J;  BGV6W2J/J57663;  4drj44j/J800103;  6KSC15J/J1801116;  FWGFC4J/J75663;   7GV6W2J/J75615;  BT9PB5J/ J75666;  JT6LW4J/ J30372;  38769917923/JTAINAN1;  F2250767/J3055503;  F1150698/ J3055496.",
      "center_classification_date": "20170512",
      "distribution_pattern": "MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA  and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.",
      "state": "NY",
      "product_description": "enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD",
      "report_date": "20170524",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-2077-2017",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "76752",
      "termination_date": "20210824",
      "more_code_info": "",
      "recall_initiation_date": "20170308",
      "postal_code": "14626-5101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}