Medical device licence · 321 · Class 2
CELL-DYN 3200 SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 9, 1998; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 321
- Licence holder
- Abbott Laboratories Diagnostics DivisionAbbott Park, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 9, 1998
- Ended
- December 9, 2025
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELL DYN 3200 DILUENT/SHEATH
- CELL DYN 3200 REAGENT CN-FREE HGB/NOC LYSE
- CELL DYN 3200 REAGENT WBC LYSE
- CELL-DYN 3200CS SYSTEM
- CELL-DYN 3200SL SYSTEM
- CELL-DYN ACCESSORY
- CELL-DYN MONITOR
- CELL-DYN RETIC-RITE CONTROL
- CELL-DYN SYSTEM RETICULOCYTE REAGENT
- WBC LYSE, CELL-DYN RUBY, CELL-DYN 3200 SYSTEMS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “cell-dyn”. A notice may cover another product or only some lots: read it to see what it covers.
- CELL-DYN Emerald System - Instrument (2019-02-26)March 15, 2019 · Medical devices · Medical devices · Type II
- CELL-DYN Ruby (2017-11-22)November 30, 2017 · Medical devices · Medical devices · Type III
- CELL-DYN EMERALD SYSTEM - CLEANER REAGENT (2016-03-29)July 4, 2016 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.