{
  "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": "219084",
      "product_res_number": "Z-1795-2026",
      "event_date_initiated": "2026-03-12",
      "event_date_posted": "2026-04-08",
      "recall_status": "Open, Classified",
      "res_event_number": "98561",
      "product_code": "QWH",
      "product_description": "B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N.  in vitro diagnostic test for Placental Growth Factor",
      "code_info": "UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)",
      "firm_fei_number": "3003561301",
      "recalling_firm": "Brahms GmbH",
      "address_1": "Neuendorfstr. 25 25 neuendorfstr.",
      "city": "Hennigsdorf",
      "country": "Germany",
      "additional_info_contact": "410 972 2452",
      "reason_for_recall": "Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve.  If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 2/27/2026, correction notices were sent to customers informing them:\n\n1. Continue to perform Quality Control testing in accordance with the current Instructions for Use prior to reporting patient results.\n2. If Quality Control results fall outside plus-minus 20% of target values follow the troubleshooting procedures described in the User Manual.\n3. Forward this letter to those who need to be aware within your organization or to any\norganization to whom the potentially affected devices have been transferred. Keep this notification on file.\n\nFor further questions, please contact the firm's customer service on 1-800-232-3342 or e-mail to: USFMTMGC-TechnicalService@thermo.com",
      "product_quantity": "5,254",
      "distribution_pattern": "Worldwide distribution. US states: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA.\n\nOther countries: DE, AT, AL, AU, BG, BR, CA, CH, CZ, DK, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA",
      "openfda": {
        "k_number": [
          "K241453",
          "DEN220027"
        ],
        "registration_number": [
          "3003561301",
          "3005847079",
          "9610126"
        ],
        "fei_number": [
          "3003561301",
          "3002806559",
          "3005847079"
        ],
        "device_name": "Prognostic Test For Development Or Progression Of Preeclampsia",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1602",
        "device_class": "2"
      }
    }
  ]
}