Vitros® 5600, 3600 and XT Systems
Brand(s)
Last updated
Summary
Product
Vitros® 5600, 3600 and XT Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76811
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