{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193157",
      "product_res_number": "Z-1052-2022",
      "event_date_initiated": "2022-04-08",
      "event_date_created": "2022-05-10",
      "recall_status": "Open, Classified",
      "res_event_number": "90012",
      "product_code": "GJS",
      "k_numbers": [
        "K122584"
      ],
      "product_description": "HemosIL ReadiPlasTin, Part No. 0020301400",
      "code_info": "UDI 08426950632887\nAll in-date lots are affected by this recall.",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory",
      "address_1": "180 Hartwell Rd",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-2443",
      "additional_info_contact": "781-861-4467",
      "reason_for_recall": "Variable and out of specification QC results with HemosIL ReadiPlasTin.  IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 8, 2022, the firm notified customers via email and certified mail. Customers were informed that the firm will stop shipment of product on May 9, 2022. After receipt of the material, customers must complete the conversion to HemosIL RecombiPlasTin 2G, with support as needed from your local Werfen representative, within 90 days.\n\nUntil a lot of HemosIL RecombiPlasTin 2G has been received and ready for use, customers should run quality control for HemosIL ReadiPlasTin with each new reagent vial (every lot) and at least every 8 hours to identify vials with performance issues. Any product with failed quality control or quality control results which trend high should be discarded. Once customers have completed the comversion to HemosIL RecombiPlasTin 2G, any remaining unused HemosIL ReadiPlasTin should be destroyed.",
      "product_quantity": "1,563 (US); 29,046 (OUS)",
      "distribution_pattern": "US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.",
      "openfda": {
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          "K903019",
          "K994006",
          "K022922",
          "K864392",
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        ],
        "registration_number": [
          "3011689956",
          "3008386529",
          "1217183",
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        "fei_number": [
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        ],
        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7750",
        "device_class": "2"
      }
    }
  ]
}