Recall MonitorHealth Products
VITROS® Chemistry Products System - LAC Slides (Lactate)
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: VITROS® Chemistry Products System - LAC Slides (Lactate)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| VITROS® Chemistry Products System - LAC Slides (Lactate) | More than 10 numbers, contact manufacturer. | 815 0112 |
| VITROS® Chemistry Products System - LAC Slides (Lactate) | More than 10 numbers, contact manufacturer. | 843 3880 |
Issue
QuidelOrtho investigated customer complaints related to the inability to successfully calibrate VITROS® LAC slides on VITROS® XT 3400 systems and VITROS® XT 7600 systems. To resolve this issue, QuidelOrtho has adjusted the assay parameter used by the reflectometer to process VITROS® LAC slides. This parameter adjustment will be implemented beginning in add DRV 6339 (and above). QuidelOrtho advises affected customers to load add DRV 6339 (or above) upon receipt. Recall start date: August 5, 2025