Z-0513-2019Class II

PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to...

Name: Z-0513-2019 PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to...
Creator: PerkinElmer Health Sciences Canada, Inc.
Published: 2018-09-24
License: https://open.fda.gov/license/

PerkinElmer Health Sciences Canada, Inc. / initiated 2018-09-24 / Terminated / root cause: software

FDA source

PerkinElmer Health Sciences Canada, Inc. began a recall of 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... on 2018-09-24. FDA classified it as Class II and gives the reason as "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...". 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-0513-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-24
Posted: 2018-11-28
Terminated: 2019-09-17
Recalling firm: PerkinElmer Health Sciences Canada, Inc.
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
Product code: DOP Mass Spectrometer, Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: Perkin Elmer issued notification on 9/24/18 customers are requested to follow instructions contained within the Urgent Medical Device Correction letter and disseminate the information to appropriate functions within their organization. Inform relevant personnel and execute one of the following two options: Qption 1 (Users who do not require Autamatic Flushinq): Deactivate the automatic flushing option in your software: 1) Navigate to the Batch Acquisition Queue tab 2) Click the Queue Options button 3) Under the "System Flush and Standby" section, DESELECT the "Enable automatic flushing" option. Option 2 (Users who require Automatic Flushinqt: Add a non data (blank or "dummy") sample to the acquisition queue to be run as your final sample (before going to Flush/standby). This will ensure that a true sample or control data are not overwritten. Contact PerkinElmer Heatth Scbnces C,arda, Bolton facility Quality Manager- SandiOrdog for further information (647. 505. 8682). The issue identified above will be addressed through a software update. PerkinElmer will contact you when the fix is available and upgrade your software.
Quantity in commerce: 18 units
Distribution: FL, MN, PA India, Italy, Korea, Spain
Product codes and lots: 210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0513-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0513-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28

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)