What's being recalled
Companies: Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, New York, United States, 14626.
How to identify it
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4200479861; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4300467456; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4400506596; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4300467455; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4400506597; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4200479860; Model or catalogue number: 684 4520
Affected products: Vitros Chemistry Products A1c Slides; Lot or serial number: 4300467446; Model or catalogue number: 684 4520
The hazard
QuidelOrtho has confirmed an issue involving Vitros chemistry products A1c slides. Certain generations (gens) of Vitros A1c slides may generate positively biased results.
As of 15-Oct-2026, QuidelOrtho has received 58 complaints relating to this issue with no reports of adverse events.
What to do
Contact the manufacturer if you require additional information.
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)