{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "189122",
      "product_res_number": "Z-0151-2022",
      "event_date_initiated": "2021-08-25",
      "event_date_created": "2021-10-19",
      "recall_status": "Open, Classified",
      "res_event_number": "88627",
      "product_code": "N/A",
      "product_description": "HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP Family, ACL TOP\nFamily 50 Seriest and ACL Elite/Elite Pro)\nPart Number: 0020302601",
      "code_info": "All currently released lots and future lots",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "SAME\n781-861-4467",
      "reason_for_recall": "Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days",
      "root_cause_description": "Device Design",
      "action": "Werfen issued Urgent Medical Device Correction letter via email  via email or registered mail on 9/7/21. Letter states reason for recall, health risk and action to take:\nNOTE: Please refer to the separate \"URGENT Medical Device Removal\" notice (dated August 25, 2021) for Hemosll Liquid Anti-Xa, Part No. 0020302600, which removes claims for this assay from the ACL Elite and ACL Elite Pro instruments.\n\" Mandatory Customer Actions\nAt this time, the on-board instrument stability claim has been reduced from 7 days to 5 days for all in-date and future product lots of Hemosll Liquid Anti-Xa (Part Nos. 0020302600 and 0020302602) on the ACL TOP Family and ACL TOP Family\n50 Series.\nPlease take the following immediate actions:\n\" Use the following reduced on-board instrument stability claim for Hemosll Liquid Anti-Xa (Part Nos. 0020302600 and 0020302602) on the ACL TOP Family and ACL TOP Family 50 Series. ACL TOP Family and ACL TOP Family 50 Series\nCurrent On-board Instrument Stability Reduced On-board Instrument Stability\n7 Days 5 Days\n\" Run quality controls before patient testing or every 8 hours and with each new vial in accordance with good laboratory practice.\n\" Post this notification on each of your ACL TOP Family and ACL TOP Family 50 Series instruments.\n\" Share this information with your staff, notifying them of the reduced on-board stability requirement of 5 Days for the ACL TOP Family and ACL TOP Family 50 Series.\n\" Retain a copy of this letter in your files as a record of the notification.\n\" Complete and return the enclosed Mandatory Response Tracking Form to acknowledge the above actions.\n\" Return the completed and signed form immediately to:\n\" Fax No.: 781-861-4207\n\" E-mail: ra-usa.na@werfen.com\nNOTE: Please return the tracking form even if you do not have any inventory of Hemosll Liquid Anti-Xa (Part Nos.\n0020302600 and 0020302602).\n\" Contact Information for Questions\n\" For technical questions, please contact the Technical Support Center at 1-8",
      "product_quantity": "40,224",
      "distribution_pattern": "US Nationwide\n\nForeign:\nCanada\nArmenia\t\t\t\t\t\t\nAustria\t\t\t\t\t\t\nAustralia\t\t\t\t\t\t\nBelgium\t\t\t\t\t\t\nBrunei\t\t\t\t\t\t\nBrazil\t\t\t\t\t\t\nBelarus\t\t\t\t\t\t\nSwitzerland\t\t\t\t\t\t\nChina\t\t\t\t\t\t\nColombia\t\t\t\t\t\t\nCzech Republic\t\t\t\t\t\t\nGermany\t\t\t\t\t\t\nDenmark\t\t\t\t\t\t\nSpain\t\t\t\t\t\t\nFinland\t\t\t\t\t\t\nFrance\t\t\t\t\t\nUnited Kingdom\t\t\t\t\t\nGibraltar\t\t\t\t\t\nGreece\t\t\t\t\t\nHong Kong\t\t\t\t\t\nHungary\t\t\t\t\t\nIndonesia\t\t\t\t\t\nIreland\t\t\t\t\t\nIsrael\t\t\t\t\t\nIndia\t\t\t\t\t\nIran\t\t\t\t\t\nItaly¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿\t\t\t\t\t\nJapan\t\t\t\t\t\t\nSouth Korea\t\t\t\t\t\t\nKuwait\t\t\t\t\t\t\nKazakhstan\t\t\t\t\t\t\nLebanon\t\t\t\t\t\t\nSri Lanka\t\t\t\t\t\t\nLithuania\t\t\t\t\t\t\nLuxembourg\t\t\t\t\t\t\nMacau\t\t\t\t\t\t\nMexico\t\t\t\t\t\t\nMalaysia\t\t\t\t\t\t\nNetherlands\t\t\t\t\t\t\nPoland\t\t\t\t\t\t\nPortugal\t\t\t\t\t\t\nQatar\t\t\t\t\t\t\nReunion\t\t\t\t\t\t\nRomania\t\t\t\t\t\t\nSerbia\t\t\t\t\t\t\nRussia\t\t\t\t\t\t\nSaudi Arabia\t\t\t\t\t\t\nSweden\t\t\t\t\t\t\nThailand\t\t\t\t\t\t\nTunisia\t\t\t\t\t\t\nTurkey\t\t\t\t\t\t\nTaiwan\t\t\t\t\t\t\nVietnam\t\t\t\t\t\t\nZambia",
      "openfda": {}
    }
  ]
}