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.
FDA Recall Z-2609-2014 · Posted 2014-09-08
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Recalling FirmAb Sciex
Recall StatusTerminated
Product CodeDOP
Date Initiated2014-07-15
Date Terminated2014-10-01
Product Quantity6 units
Reason for Recall
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Firm 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.
Root Cause
Software design
Distribution Pattern
FL, NC, OK, PA, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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