U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Mass spectrometer, clinical use - Product Code DOP
원인
Software- ab sciex api 3200md lc/ms/ms system with multiquantmd 3.0 software may provide incorrect data for patient diagnosis.
조치
AB SIEX issued letter on 7/15/14, notifying customers to implement this field correction, a temporary fix to be implemented immediately.
Additionally, a software update is in development and is expected to be available in approximately 8 weeks. Upon availability, AB SCIEX will send a DVD with instructions on how to install the new software update. At that time, outlined temporary actions will no longer be necessary.
If you have any questions regarding this recall, potential hazards or actions to be taken please feel free to contact AB SCI EX at +1 289 982 2531.
Please confirm receipt of this letter by signing and faxing back the attached Acknowledgement Form.
AB SCIEX API 3200MD" LC/MS/MS System with software: || MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens || Part Number 5024543.