Ab Sciex: Medical Device Recall in 2016 - (Recall #: Z-1586-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: May 11, 2016

Recall Number: Z-1586-2016

Event ID: 73433

Reason for Recall:

Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.

Status: Terminated

Product Quantity: 279

Code Information:

Software Versions: Version 1.6.1 and 1.6.2

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated