Devices

ADVIA 1200 Chemistry System

  • 모델명 / 제조번호(시리얼번호)
    All ADVIA 1200 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1200 Part # 094-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • 제품 설명
    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)
  • 1 Event

제조사

Bayer Healthcare, LLC (Diagnostics Division)
  • 제조사 주소
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 19 건

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Device Recall ADVIA 1200 Chemistry System
  • 모델명 / 제조번호(시리얼번호)
    Part No. 094-A001; all Advia Chemistry System units and serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA and Puerto Rico.
  • 제품 설명
    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
  • Manufacturer
    Bayer Healthcare, LLC (Diagnostics Division)
ADVIA 1200 Chemistry System - Registration No. 10345160456; ADVIA 1650 Chemistry System - Registr...
ADVIA 1200 Chemistry System; ADVIA 1650 Chemistry System; ADVIA 1800 CHEMISTRY SYSTEM; ADVIA 2400...
Trade Names: Advia 1650 Chemistry System, registration 10345160453; Advia 1200 Chemistry System, ...
ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 00141230 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02189346 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03039070 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07371282 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03036926 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02193432 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03056927 (Lot serial: > 10 numbers contact mfg); Model Catalog: 04993452 (Lot serial: > 10 numbers contact mfg); Model Catalog: 01803350 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03051194 (Lot serial: > 10 numbers contact mfg); Model Catalog: 02271328 (Lot serial: > 10 numbers contact mfg); Model Catalog: 06837459 (Lot serial: > 10 numbers contact mfg); Model Catalog: (Lot serial: > 10 numbers contact mfg); Model Catalog: 07989138 (Lot serial: > 10 numbers contact mfg); Model Catalog: 03035814 (Lot serial: > 10 numbers contact mfg); Model Catalog: 07498649 (Lot serial: > 10 numbers contact mfg); Model C
  • 제품 설명
    ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED
하나 더 14 건 더