Vitros® 5600, 3600 and XT Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Vitros® 5600 Integrated System |
Not applicable. |
680 2413 |
Vitros® 3600 Immunodiagnostic System-Instrument |
Not applicable. |
680 2914 |
Vitros® XT 7600 Integrated System |
Not applicable. |
6272222 |
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
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
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