Medical device licence · 60365 · Class 2
COULTER CELLPREP
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 27, 2002; ended October 26, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60365
- Licence holder
- Beckman Coulter, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- August 27, 2002
- Ended
- October 26, 2015
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COULTER CELLPREP
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 “coulter”. A notice may cover another product or only some lots: read it to see what it covers.
- Beckman Coulter AU Immunochemistry System - AU480 AnalyzerAugust 6, 2026 · Chemistry · Performance · Type II
- Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol AssayDecember 10, 2025 · Chemistry · Performance · Type II
- Coulter DxH DiluentNovember 26, 2025 · Medical devices · Performance · Type II
- Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) AssayOctober 17, 2025 · Chemistry · Performance · Type II
- Beckman Coulter Au Immunochemi Sys- Unsaturated Iron Binding Capacity (UIBC)July 9, 2025 · Chemistry · Performance · Type II
- Beckman Coulter Au Immunochemistry System - Apolipoprotein BMay 7, 2025 · Chemistry · Labelling and packaging · Type II
- Beckman Coulter Au480 and Au680 Immunochemistry SystemsMay 7, 2025 · Chemistry · Performance · Type II
- Beckman Coulter Access Erythropoetin ReagentApril 9, 2025 · Chemistry - Haematology · Performance · Type II
- Beckman Coulter Au Immunochemistry System- Immunoglobulin M (IgM)June 7, 2024 · Chemistry · Performance · Type II
- Beckman Coulter Au2700/5400 Immunochemistry System - Transferrin AssaySeptember 18, 2023 · Chemistry - Immunology · Performance · Type II
- Beckman Coulter Au 2700/5400 Immunochemistry System - Immunoglobulin A (IgA)August 3, 2023 · Chemistry · Performance · Type II
- Beckman Coulter Thyroglobulin AssayJuly 19, 2023 · Chemistry - Immunology · Performance · Type II
- Coulter Dxh DiluentJune 8, 2023 · Medical devices · Performance · Type II
- Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) AssayApril 13, 2023 · Chemistry · Performance · Type II
- Beckman Coulter Immunochemistry System - Magnesium AssayDecember 31, 2021 · Medical devices · Increased risk or new adverse events · Type II
- Beckman Coulter AU System - Liquid Urine Chemistry Calibrator (2020-02-05)February 28, 2020 · Medical devices · Medical devices · Type III
- UniCel DxH 600, 800, and 900 Coulter Cellular Analysis System (2018-08-01)June 4, 2019 · Medical devices · Medical devices · Type I
- Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer (2018-11-12)November 30, 2018 · Biologic or vaccine - Medical devices · Medical devices · Type III
- Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer (2018-06-12)October 19, 2018 · Medical devices · Medical devices · Type III
- Coulter DxH Cleaner (2017-12-04)April 24, 2018 · Medical devices · Medical devices · Type III
- COULTER EPICS Flow Cytometers, Cytomics FC500 Flow Cytometer, Cytomics FC 500 MPL (Flow Cytometer) and EPICS XL/MCL Analyzer (2018-01-08)January 16, 2018 · Medical devices · Medical devices · Type I
- Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis SystemJuly 17, 2017 · Medical devices · Type II
- Hmx Hematology Analyzer and Coulter Lh Analyzers (2017-06-19)July 11, 2017 · Medical devices · Medical devices · Type II
- Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis SystemJuly 11, 2017 · Medical devices · Type II
- Coulter PrepPlus and PrepPlus 2 (2017-05-22)June 13, 2017 · Medical devices · Medical devices · Type II
- Unicel Dxh 800 and 600 Coulter Cellular Analysis System (2017-04-25)May 16, 2017 · Medical devices · Medical devices · Type II
- Beckman Coulter Reagents (2017-04-03)May 2, 2017 · Medical devices · Medical devices · Type II
- UniCel DxH 600 and 800 Coulter Cellular Analysis Systems (2016-12-19)January 12, 2017 · Medical devices · Medical devices · Type II
- Beckman Coulter AU Immunochemistry Sytem-AU680 InstrumentDecember 13, 2016 · Medical devices · Type III
- Coulter Body Fluid Control Level 1November 16, 2016 · Medical devices · Type III
- UNICEL DXH 800/600 COULTER CELLULAR ANALYSIS SYSTEM (2016-08-08)August 19, 2016 · Medical devices · Medical devices · Type II
- COULTER ACT DIFF2 and UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (2016-07-08)July 29, 2016 · Medical devices · Medical devices · Type III
- UNICEL DXH 600/800 COULTER CELLULAR ANALYSIS SYSTEM (2016-05-02)May 16, 2016 · Medical devices · Medical devices · Type III
- Beckman Coulter Immunochemistry System Assays (2016-04-11)April 19, 2016 · Medical devices · Medical devices · Type I
- COULTER S-CAL CALIBRATOR KITS (2015-12-14)January 18, 2016 · Medical devices · Health products · Type II
- UNICEL DXH COULTER ANALYSIS SYSTEM (2015-12-01)January 7, 2016 · Medical devices · Health products · Type II
- COULTER DILUENTS (2015-09-04)October 14, 2015 · Medical devices · Health products · Type III
- COULTER ACT REAGENT KITS (2015-08-24)October 5, 2015 · Medical devices · Health products · Type II
- BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM ANALYZERS (2015-07-30)September 8, 2015 · Medical devices · Health products · Type III
- COULTER LH SERIES DILUENT (2015-07-20)August 11, 2015 · Medical devices · Health products · Type II
- UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (2015-06-23July 17, 2015 · Medical devices · Health products · Type III
- UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEMS (2015-06-29)July 17, 2015 · Medical devices · Health products · Type III
- COULTER BODY FLUID CONTROL KIT, LEVEL 1 (2015-06-01)July 7, 2015 · Medical devices · Health products · Type III
- Bicarbonate Reagents for Beckman Coulter AU analyzers (2015-02-17)May 21, 2015 · Medical devices · Health products · Type III
- COULTER DXH DILUENT (2015-04-10)May 1, 2015 · Medical devices · Health products · Type II
- Beckman Coulter AU,AU2700 and AU5400 Immunochemistry System Reagents (2014-12-08)December 23, 2014 · Medical devices · Medical devices · Type II
- COULTER 5C Cell Control, Abnormal II (2014-12-01)December 11, 2014 · Medical devices · Medical devices · Type III
- Coulter HMX Hematology Analyzers and Coulter IH 500 Series System (2014-10-20)October 29, 2014 · Medical devices · Medical devices · Type III
- Coulter DXH Diluent (2014-08-25)September 25, 2014 · Medical devices · Medical devices · Type II
- Bekman Coulter AU Immunochemistry System-AU480 (2013-09-03)September 16, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.