Recall MonitorHealth Products
Vitros® 5600, 3600 and XT Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Vitros® 5600, 3600 and XT Systems
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® 5600 Integrated System | Not applicable. | 680 2413 680 2915 |
| Vitros® 3600 Immunodiagnostic System-Instrument | Not applicable. | 680 2914 680 2783 |
| Vitros® XT 7600 Integrated System | Not applicable. | 6272222 684 4461 |
Issue
During internal testing, QuidelOrtho™ identified that microwell assay results have the potential to be reported without the reagent expired (re) result code, even when the signal reagent (sr) pack is past the expiry date. This can occur when an sr pack exceeds the on-board expiry and/or the shelf expiration date. This issue can affect any microwell assay regardless of whether or not the system is configured to use expired reagents. Recall start date: December 24, 2024