{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "114824",
      "product_res_number": "Z-0614-2013",
      "event_date_initiated": "2012-10-11",
      "event_date_posted": "2012-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-09-11",
      "res_event_number": "63814",
      "product_code": "JJH",
      "product_description": "COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5\n\nAutomated sample processing instrument used with CAP/CA and CAP/CTM.\n\nRoche Molecular Systems, Inc.\n1080 US Highway 202 South\nBranchburg, NJ 08876\nUSA\nMade in Switzerland",
      "code_info": "CAP 394436 to 394663",
      "firm_fei_number": "2243471",
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "address_1": "1080 Us Highway 202 S 1080 Us Highway 202",
      "city": "S Branchburg",
      "state": "NJ",
      "postal_code": "08876-3733",
      "additional_info_contact": "Mr. Vincent Stagnitto\n908-253-7569",
      "reason_for_recall": "Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.",
      "root_cause_description": "Device Design",
      "action": "Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers.  The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information.  Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments.  Also, the letter should be filed for future reference.  Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.",
      "product_quantity": "7 units",
      "distribution_pattern": "Distributed in the states of GA, CA, NC, and MN.",
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}