FDA Medical Device Recalls (openFDA)
PerkinElmer Health Sciences Canada, Inc.: 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
- Recall number
- Z-0513-2019
- 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
- Status
- Terminated
- Initiated
- 2018-09-24
- Posted
- not on file
- Terminated
- 2019-09-17
- Reason
- 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
- 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
- 18 units
- Distribution
- FL, MN, PA India, Italy, Korea, Spain
- Lot, serial or model codes
- 210MDBC709100008 210MD8C709140010 210MD8C709150009 210MDBC709160011 210MDBC709180012 210MDBC709200013 210MD8C710020014 210MDBC710050016 210MD8C710110018 210MDBC710170020 210MD8C710180022 210MD8C712220428 210MDBC801240030 210MDBC801250031 210MDBC802140032 210MD8C802150033 210MD8C802260035 210MDBC803190037
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DOP
- Firm FEI
- 3013944243
- Firm city
- Bolton
- Firm state
- not on file
- Firm country
- Canada
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