Devices

Device Recall D10 Dual Program

  • 모델명 / 제조번호(시리얼번호)
    Diluent lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers 2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745, 2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for 2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent that comes with the kit has an expiration date of AA61408
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.
  • 제품 설명
    Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
  • Manufacturer
    Bio-Rad Laboratories Inc
  • 1 Event

제조사

Bio-Rad Laboratories Inc
  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA

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Device Recall D10 Dual Program Reorder Pack
  • 모델명 / 제조번호(시리얼번호)
    Model number 220-0201; Kit Lot number/Expiration date: 20010663/Sept 2012; 20010665-A/Sept 2012; 20010665-B/Sept 2012; 20010665-C/Sept 2012.  Elution Buffer Lot numbers: AA10434, AA10435; Exp 9/30/2012
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. Korea.
  • 제품 설명
    D-10 Dual Program Reorder Pack; || contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. || Bio-Rad Laboratories Inc. Hercules, CA. || Product Usage: || Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use.
  • Manufacturer
    Bio-Rad Laboratories Inc
Device Recall D10 Dual Program, Update Kit D10 A1c program diskette
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014  64000331 5/31/2014  64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014   ( 64002240 08/3112014  64002241 11/30/2014
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
  • 제품 설명
    D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. || United States; Bio-Rad Laboratories, || Hercules, CA 94547 || The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
  • Manufacturer
    Bio-Rad Laboratories, Inc.