Z-2528-2016Class II

AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part...

Name: Z-2528-2016 AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part...
Creator: Ab Sciex
Published: 2016-06-16
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2016-06-16 / Terminated / root cause: software

FDA source

Ab Sciex began a recall of AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD... on 2016-06-16. FDA classified it as Class II and gives the reason as "MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature". 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-2528-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-16
Posted: 2016-08-12
Terminated: 2017-03-02
Recalling firm: AB Sciex, LLC
Product: AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
Product code: DOP Mass Spectrometer, Clinical Use
Reason for recall: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Root cause tag: software
FDA root cause: Software design
Action: AB SCIEX issued recall notification by letter dated June 16, 2016, to all affected customers. The letter identified the problem, provided temporary measures until a permanent software is available. A response form was to be completed and returned. questions regarding this notice contact SCI EX at +1 289 982 2712.
Quantity in commerce: 121 units
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
Product codes and lots: Software Version: MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2526-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12
Z-2527-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12
Z-2528-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12
Z-2529-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-12

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)