Z-1586-2016Class II

Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System...

Name: Z-1586-2016 Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System...
Creator: Ab Sciex
Published: 2016-02-24
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2016-02-24 / Terminated / root cause: software

FDA source

Ab Sciex began a recall of Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP... on 2016-02-24. FDA classified it as Class II and gives the reason as "Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect 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-1586-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-04-29
Terminated: 2017-02-06
Recalling firm: AB Sciex, LLC
Product: Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP 4500MD LC/MS/MS System, Instrument Part Number: 5031231 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: Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Root cause tag: software
FDA root cause: Software design
Action: Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531.
Quantity in commerce: 279
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
Product codes and lots: Software Versions: Version 1.6.1 and 1.6.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1586-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1586-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-04-29

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)