Recall Z-2609-2014 ยท DOP Mass Spectrometer, Clinical Use
Ab Sciex
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.
| Date | Sep 8, 2014 (initiated Jul 15, 2014) |
| Status | Terminated |
| Reason | Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis |
| Root cause | Software design |
| Action | 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 th |
| Quantity | 6 units |
| Distribution | FL, NC, OK, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.