Medical device licence · 91636 · Class 3
SPOTCHECK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91636
- Licence holder
- Astoria-Pacific, Inc.Clackamas, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 10, 2013
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPOTCHECK - BIOTINIDASE MICROPLATE REAGENT KIT
- SPOTCHECK - BLOOD SPOT CONTROLS
- SPOTCHECK - NEONATAL GALT MICROPLATE REAGENT KIT
- SPOTCHECK - PRO
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 “spotcheck”. A notice may cover another product or only some lots: read it to see what it covers.
- SPOTCHECK SystemAugust 21, 2024 · Haematology · Performance · Type II
- Spotcheck - Neonatal Galt Microplate Reagent KitJanuary 2, 2024 · Haematology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.