Z-1671-2016Class II

AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No...

Name: Z-1671-2016 AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No...
Creator: Ab Sciex
Published: 2016-03-25
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2016-03-25 / Terminated

FDA source

Ab Sciex began a recall of AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic... on 2016-03-25. FDA classified it as Class II and gives the reason as "Under certain conditions, mass spectrometers may report incorrect quantitative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1671-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-05-15
Terminated: 2016-05-23
Recalling firm: AB Sciex, LLC
Product: AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
Product code: DOP Mass Spectrometer, Clinical Use
Reason for recall: Under certain conditions, mass spectrometers may report incorrect quantitative results.
FDA root cause: Under Investigation by firm
Action: AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531.
Quantity in commerce: 2 units
Distribution: Distributed to the state of NC.
Product codes and lots: Serial Numbers: Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602 QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-15

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)