{
  "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": "Bedford",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89894",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "address_2": "",
      "postal_code": "01730-2443",
      "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 and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, S. Tome, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad, Tobago, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam.",
      "recall_number": "Z-1014-2022",
      "product_description": "ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:  Name Part Number   1.ACL TOP 300 CTS 00000280060   2. ACL TOP 300 CTS  00000280060R (Refurbished)  3. ACL TOP 350 CTS 00000280065   4. ACL TOP 500 CTS 00000280040   5. ACL TOP 500 CTS 00000280040R  ( Refurbished)  6/  6. ACL TOP 550 CTS 00000280045   7. ACL TOP 970 CL   00000280097",
      "product_quantity": "2725 units US: 5,572 units OUS.UPDATE: 2727 units US; 5277 units OUS",
      "reason_for_recall": "Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe",
      "recall_initiation_date": "20220222",
      "center_classification_date": "20220428",
      "report_date": "20220504",
      "code_info": "All Serial Numbers.    Trade Name    Part Number      UDI       ACL TOP 300 CTS    00000280060     08426950556916;       \"ACL TOP 300 CTS  (Refurbished)\"    00000280060R    08426950928027;       ACL TOP 350 CTS    00000280065     08426950784081;       ACL TOP 500 CTS    00000280040     08426950453499;       \"ACL TOP 500 CTS  (Refurbished)\"    00000280040R     08426950928003;       ACL TOP 550 CTS    00000280045      08426950729242;       ACL TOP 970 CL    00000280097      08430793045476.",
      "more_code_info": ""
    }
  ]
}