FDA recall Z-0513-2019

Product

PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872

Reason for recall

Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acquired sample to be over-written when the automatic flush is enabled.

Distribution

FL, MN, PA India, Italy, Korea, Spain

Key facts

Status

Terminated

Initiation date

2018-09-24

Report date

2018-12-05

Termination date

2019-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bolton, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2019