Devices

ADVIA 1200 Chemistry System

  • Model / Serial
    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.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

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

19 devices with a similar name

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Device Recall ADVIA 1200 Chemistry System
  • Model / Serial
    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.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and Puerto Rico.
  • Product Description
    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
  • Model / Serial
    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
  • Product Description
    ADVIA 1200 CHEMISTRY SYSTEM - LITHIUM (LITH) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED
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