Device product
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Z-1586-2016
Product summary
- Firm
- Ab Sciex
- Event
- Event 73433
- Status
- Terminated
- Classification
- Class II
- Quantity
- 279
- Official record key
device-enforcement:Z-1586-2016
Official wording
Reason: Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Code information: Software Versions: Version 1.6.1 and 1.6.2
Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
Derived failure modes
-
Unknown
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.