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An official Health Canada notice concerns Directcheck™ whole blood control. 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. Published 2026-05-14.
What to do now
Customer notification letter to be sent. Instructions to be provided on disposal of affected units
Recall number
82075
Official notice
2026-05-14
The hazard
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Company & contacts
Brand: Bionostics.
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