AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic

FDA device recall Z-2609-2014 · posted 2014-09-08 · Terminated

Recall details

Recalling firm

Ab Sciex

Reason for recall

Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

DOP

Quantity affected

6 units

Distribution

FL, NC, OK, PA, TX

Date initiated

2014-07-15

Date posted

2014-09-08

Date terminated

2014-10-01

Location

Framingham, MA