Recall Z-1586-2016
Ab Sciex · initiated February 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Software Versions: Version 1.6.1 and 1.6.2
Reason for recall
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
FDA-determined cause: Software design
Action taken
Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531.
Details
- Recall number
- Z-1586-2016
- Initiated
- February 24, 2016
- Posted by FDA
- April 29, 2016
- Terminated
- February 6, 2017
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Quantity
- 279
- Distribution
- 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
- Recalling firm
- Ab Sciex, Framingham, MA