{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Westlake",
      "address_1": "810 Sharon Dr",
      "reason_for_recall": "Negative drift on QC during in-use lifetime of CREA membranes can be observed.",
      "address_2": "",
      "product_quantity": "10,824 boxes",
      "code_info": "Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward:  Affected lot numbers  942-073R0465  942-073R0468  942-073R0469  942-073R0470  942-073R0471  942-073R0472  942-073R0474  942-073R0475  942-073R0476  942-073R0478  942-073R0479  942-073R0480  942-073R0481  942-073R0482  942-073R0487  942-073R0488  942-073R0489  942-073R0490  942-073R0491  942-073R0492  942-073R0493  942-073R0494  942-073R0495  942-073R0496  942-073R0497  942-073R0498  942-073R0499  942-073R0500  942-073R0501  942-073R0502  942-073R0503  942-073R0504  942-073R0507  942-073R0509  942-073R0510  942-073R0511  942-073R0512  942-073R0513  942-073R0515  942-073R0518  942-073R0520  942-073R0521  942-073R0522  942-073R0523  942-073R0524  942-073R0525  942-073R0526  942-073R0527  942-073R0528  942-073R0529  942-073R0530  942-073R0532  942-073R0533  942-073R0534  942-073R0535  942-073R0536  942-073R0537  942-073R0538  942-073R0539  942-073R0540  942-073R0541  942-073R0542  942-073R0544  942-073R0545  942-073R0546  942-073R0548  942-073R0549  942-073R0550  942-073R0551  942-073R0553  942-073R0555  942-073R0556  942-073R0557  942-073R0558  942-073R0560  942-073R0561  942-073R0562  942-073R0564  942-073R0565  942-073R0566  942-073R0567  942-073R0569  And onwards: The firm is still determining the scope of how many lot numbers are affected.",
      "center_classification_date": "20150318",
      "distribution_pattern": "Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerland, Russian Federation, Netherlands, Czech Republic, Mexico, Brazil, Czechoslovakia, Austria, Singapore, Syria, Phillipines, Egypt, Bolivia, Japan, New Zealand, Turkey, Saudi Arabia, Algeria, Qatar, and Finland.",
      "state": "OH",
      "product_description": "Crea A and B membranes, packaged 4 per box  Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.",
      "report_date": "20150325",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Radiometer America Inc",
      "recall_number": "Z-1293-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69813",
      "termination_date": "20150702",
      "more_code_info": "",
      "recall_initiation_date": "20141029",
      "postal_code": "44145-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}