Z-2609-2014Class II

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

Name: Z-2609-2014 AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic...
Creator: Ab Sciex
Published: 2014-07-15
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2014-07-15 / Terminated / root cause: software

FDA source

Ab Sciex began a recall of 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... on 2014-07-15. FDA classified it as Class II and gives the reason as "Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2609-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-15
Posted: 2014-09-08
Terminated: 2014-10-01
Recalling firm: AB Sciex, LLC
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.
Product code: DOP Mass Spectrometer, Clinical Use
Reason for recall: Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Root cause tag: software
FDA 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 in commerce: 6 units
Distribution: FL, NC, OK, PA, TX
Product codes and lots: Serial Numbers: BV20031308, BV20081311, BV20051310, BV20071311, BV20101401, BV20131401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2609-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2609-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)