Recall Z-2528-2016 ยท DOP Mass Spectrometer, Clinical Use
Ab Sciex
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
| Date | Aug 12, 2016 (initiated Jun 16, 2016) |
| Status | Terminated |
| Reason | MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature. |
| Root cause | Software design |
| Action | 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. |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.