Devices

Device Recall IL

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
  • Source
    USFDA

7 devices with a similar name

Learn more about the data here

Device Recall ILLINOIS (TJ) NEEDLE ASPIRATION
  • Model / Serial
    Product Code: a.) TIN3015/ LOT 0000836578, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849715, 0000850938, 0000852076, 0000854859; Product Code: b.) TIN3018/ LOT 0000836574, 0000841212, 0000852078
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
  • Product Description
    ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
  • Manufacturer
    Carefusion 2200 Inc
Device Recall iLab
  • Model / Serial
    Model Numbers M0004EPiL120CART0, serial number 4037; H749iLab120CART0, serial numbers 4041, 4020, 4056, 4018, 4037; H749iLab120CARTD0, serial number 4064; H749iLab120CARTR0, serial number 4022; H749iLab120INS0, serial numbers 4016, 4015, 4008, 4043.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 13 US consignees and 10 foreign consignees.
  • Product Description
    iLab Utrasound Imaging System, software controlled Imaging Catheter.
  • Manufacturer
    Boston Scientific Target
Device Recall IL GEM PCL/PCL Plus Gem Test PT Cartridge
  • Model / Serial
    ID #: 6260030000.  Lot Numbers:  A1ILJPT001, H0ILJPT005, and K0ILJPT006.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.
  • Product Description
    IL GEM PCL/PCL Plus - Gem Test PT Cartridge || ITC-Nexus Dx || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.
  • Manufacturer
    International Technidyne Corp.
Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
  • Model / Serial
    Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: MD, NY Non-US: France
  • Product Description
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
  • Manufacturer
    Illumina Inc
Device Recall ILED Surgical Light
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