Devices

Device Recall GEM Check Coag Whole Blood Controls

  • 모델명 / 제조번호(시리얼번호)
    Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • 제품 설명
    GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: || IVD. 15/pk. 06260061600. || Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation
  • 1 Event

제조사

International Technidyne Corporation
  • 제조사 주소
    International Technidyne Corporation, 20 Corporate Pl S, Piscataway NJ 08854-6144
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA

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Device Recall GEM Check Coag Whole Blood Controls
  • 모델명 / 제조번호(시리얼번호)
    Part Number 0620060100 Lot # F9GC2001, Exp. 12/31/2010; and L9GC2002, Exp. 5/31/2011.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • 제품 설명
    GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk. || Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation