Recall Z-1671-2016
Ab Sciex · initiated March 25, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Under certain conditions, mass spectrometers may report incorrect quantitative results.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1671-2016
- Initiated
- March 25, 2016
- Terminated
- May 23, 2016
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Quantity
- 2 units
- Distribution
- Distributed to the state of NC.
- Recalling firm
- Ab Sciex, Framingham, MA