Recall Z-2528-2016
Ab Sciex · initiated June 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 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.
Codes / lots: Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
Reason for recall
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
FDA-determined cause: Software design
Action taken
AB SCIEX issued recall notification by letter dated June 16, 2016, to all affected customers. The letter identified the problem, provided temporary measures until a permanent software is available. A response form was to be completed and returned. questions regarding this notice contact SCI EX at +1 289 982 2712.
Details
- Recall number
- Z-2528-2016
- Initiated
- June 16, 2016
- Posted by FDA
- August 12, 2016
- Terminated
- March 2, 2017
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Quantity
- 121 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
- Recalling firm
- Ab Sciex, Framingham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2526-2016 Class II | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF):…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | 06/16/2016Terminated |
| Z-2527-2016 Class II | AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use.…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | 06/16/2016Terminated |
| Z-2529-2016 Class II | AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use.…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | 06/16/2016Terminated |