Product Wiki · Recalls · Health Canada — Medical Devices

directCHECK™ Whole Blood Control — recall 82075

Health Canada — Medical Devices · Canada · 2026-05-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
82075
Date of alert
2026-05-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Haematology
Product type
Medical devices
Reported risk: Instances of consistently elevated results were identified when using directCHECK™ Whole Blood Control DCGLR‑2, lot A6DLA001. A process error led to testing the lot on the wrong instrument platform, which resulted in the creation and release of incorrect Quality Control (QC) ranges on the performance range card distributed with this lot.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/directchecktm-whole-blood-cont

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