{
  "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": [
    {
      "status": "Terminated",
      "city": "Marcy L'Etoile",
      "state": "N/A",
      "country": "France",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80111",
      "recalling_firm": "BioMerieux SA",
      "address_1": "Chemin De L'Orme",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "International distribution.",
      "recall_number": "Z-2170-2018",
      "product_description": "The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method.    The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label.     An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.",
      "product_quantity": "FUCHSIN-A (ref: 29522)  15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches",
      "reason_for_recall": "A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.",
      "recall_initiation_date": "20180323",
      "center_classification_date": "20180612",
      "termination_date": "20200623",
      "report_date": "20180620",
      "code_info": "Reagents for use with the PREVI¿ Color Gram:    IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18  CRYSTAL VIOLET-C (ref: 29524)  Lot number: G52306  Exp.19-Jul-18  FUCHSIN-A (ref: 29522): Lot Number  Lot number: F89544  Exp. 13-Apr-18"
    }
  ]
}