{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "198457",
      "product_res_number": "Z-1268-2023",
      "event_date_initiated": "2023-01-27",
      "event_date_posted": "2023-08-29",
      "recall_status": "Open, Classified",
      "res_event_number": "91665",
      "product_code": "MRR",
      "k_numbers": [
        "K982529"
      ],
      "product_description": "Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer.\nSMN: 11097632",
      "code_info": "UDI: 00630414596181\nAll Lots",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "SAME\n914-631-8000",
      "reason_for_recall": "Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Issued  Urgent Field Notice to US customers ACHC23-01.B.US via FedEx beginning on 01/30/2023. In accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities customers for distribution.\n and regional reporting to their local competent authorities beginning on 01/27/2023.\n\nThe UMDC/UFSN provides instructions to all Atellica CH 930 customers to either\nseparate the assays causing carryover by analyzer, if they have multiple analyzers, or by\nbatch testing of Mg. In addition, the UMDC and UFSN indicates that SW v1.27 and\nhigher will correct this issue.\n\nLetter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director. Perform the instructions provided in the  Additional Information  section. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\nContact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "8420 units",
      "distribution_pattern": "Nationwide\nForeign:\nCountry\nAlbania\nAlgeria\nArgentina\nAustralia\nAustria\nBahrain\nBangladesh\nBelgium\nBrazil\nBulgaria\nBurkina Faso\nCanada\nChile\nChina\nColombia\nCroatia\nCura¿ao\nCzech Republic\nDenmark\nEcuador\nEgypt\nFinland\nFrance\nGermany\nGreece\nGuadeloupe\nHong Kong\nHungary\nIndia\nIreland\nIsrael\nItaly\nJapan\nKuwait\nLibya\nMalaysia\nMexico\nNetherlands\nNew Zealand\nNorway\nOman\nPakistan\nParaguay\nPeru\nPhilippines\nPoland\nPortugal\nQatar\nRepublic Korea\nRomania\nSaudi Arabia\nSerbia\nSingapore\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSweden\nSwitzerland\nTaiwan, Province of China\nThailand\nUkraine\nUnited Arab Emirates\nUnited Kingdom Great Britain\nUruguay\nVatikancity\nVietnam",
      "openfda": {
        "k_number": [
          "K955904",
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          "K012287",
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          "K020724",
          "K063841",
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          "K924674",
          "K020575",
          "K040693",
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          "K090734",
          "K041720",
          "K964063",
          "K091333",
          "K241800",
          "K981978",
          "K964064",
          "K051121",
          "K161691"
        ],
        "registration_number": [
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        "fei_number": [
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          "3000215862",
          "2432235",
          "1000305841",
          "1000122044"
        ],
        "device_name": "System, Test, Low Density, Lipoprotein",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1475",
        "device_class": "1"
      }
    }
  ]
}