Device 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.
Z-2609-2014
Product summary
- Firm
- Ab Sciex
- Event
- Event 68821
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-2609-2014
Official wording
Reason: Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Code information: Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401
Distribution pattern: FL, NC, OK, PA, TX
Derived failure modes
-
Device software or design
software may provide incorrect