Device product
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.
Z-1671-2016
Product summary
- Firm
- Ab Sciex
- Event
- Event 73786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1671-2016
Official wording
Reason: Under certain conditions, mass spectrometers may report incorrect quantitative results.
Code information: Serial Numbers: Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602 QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602
Distribution pattern: Distributed to the state of NC.
Derived failure modes
-
Unknown
Under certain conditions, mass spectrometers may report incorrect quantitative results.