FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2609-2014
- Recalling firm
- Ab Sciex
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-07-15
- Posted
- 2014-09-08
- Terminated
- 2014-10-01
- 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 this letter by signing and faxing back the attached Acknowledgement Form.
- Quantity
- 6 units
- Distribution
- FL, NC, OK, PA, TX
- Lot, serial or model codes
- Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401
- 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