CanadadirectCHECK™ Whole Blood Control (model DCGLR‑2), lot A6DLA001, sold by Bionostics Inc is affected; you can recognise affected product by the model/catalogue number DCGLR‑2 and lot number A6DLA001. A process error resulted in testing the lot on the wrong instrument platform and the release of incorrect quality control ranges, producing instances of consistently elevated results. A customer notification letter will be sent and instructions will be provided on disposal of affected units.
What's being recalled
Companies: Bionostics Inc, 7 Jackson Road, Devens, Massachusetts, United States, 01434.
How to identify it
Affected products: directCHECK™ Whole Blood Control; Lot or serial number: A6DLA001; Model or catalogue number: DCGLR‑2
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.
What to do
Customer notification letter to be sent. Instructions to be provided on disposal of affected units
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)