FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1671-2016
- Recalling firm
- Ab Sciex
- 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.
- Status
- Terminated
- Initiated
- 2016-03-25
- Posted
- not on file
- Terminated
- 2016-05-23
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 3008935545
- Firm city
- Framingham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28