FDA Medical Device Recalls (openFDA)
Ab Sciex: 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.
- Recall number
- Z-1586-2016
- Recalling firm
- Ab Sciex
- 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.
- Status
- Terminated
- Initiated
- 2016-02-24
- Posted
- 2016-04-29
- Terminated
- 2017-02-06
- Reason
- Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
- 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
- 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
- Lot, serial or model codes
- Software Versions: Version 1.6.1 and 1.6.2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 3008935545
- Firm city
- Framingham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28