Recall Z-1671-2016 ยท DOP Mass Spectrometer, Clinical Use
Ab Sciex
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
| Date | Mar 25, 2016 |
| Status | Terminated |
| Reason | Under certain conditions, mass spectrometers may report incorrect quantitative results. |
| Root cause | Under Investigation by firm |
| Action | AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531. |
| Quantity | 2 units |
| Distribution | Distributed to the state of NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.