{
  "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": "2026-03-18",
    "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": "92831",
      "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 Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.",
      "recall_number": "Z-2578-2023",
      "product_description": "ACL TOP Family 50 Series Models as follows:  In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis                                                    (1) ACL TOP 550 CTS\t\tModel Number: 00000280045;\t\t\t\t\t  (2) ACL TOP 750 CTS\t\tModel Number: 00000280055;\t\t\t\t\t  (3) ACL TOP 350 CTS\t\tModel Number: 00000280065;\t\t\t\t\t  (4) ACL TOP 750\t\t\tModel Number: 00000280015;\t\t\t\t\t  (5) ACL TOP 750 LAS\t\tModel Number: 00000280035\t\t\t\t\t  (6) ACL TOP 970 CL(only available ROW)Model Number:  00000280097",
      "product_quantity": "2,068 kits US: 6,270 units OUS",
      "reason_for_recall": "Sample misidentification could occur under specific   conditions and patient management altered based on an incorrectly assigned result",
      "recall_initiation_date": "20230713",
      "center_classification_date": "20230912",
      "report_date": "20230920",
      "code_info": "Model Names           UDI   (1)ACL TOP 550 CTS  08426950729242;   (2)ACL TOP 750 CTS  08426950784067;   (3)ACL TOP 350 CTS  08426950784081;   (4) ACL TOP 750   08426950784074;  (5) ACL TOP 750 LAS  08426950784050   (6) ACL TOP 970 CL  08430793045476    Software: 1)ACL TOP 550 CTS  v6.3.0 or later;  (2)ACL TOP 750 CTS  v6.3.0 or later;   (3)ACL TOP 350 CTS  v6.3.0 or later;   (4) ACL TOP 750   v6.3.0 or later;  (5) ACL TOP 750 LAS  v6.3.0 or later;   (6) ACL TOP 970 CL  Version 1.1.0 (OUS).    UPDATE: 10/16/23 Affected Serial Number Range                                 Start SN  End SN  ACL TOP 350 CTS     21113058  23074369;  ACL TOP 550 CTS     21112046  23072623;  ACL TOP 750           22010516  23060671; ACL TOP 750 CTS     21110860  23071015;  ACL TOP 750 LAS     21120879  23071077",
      "more_code_info": ""
    }
  ]
}