Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and Recalled by Ortho Clinical Diagnostics Due to Modifications to MicroWell Qualitative Assay Parameters Not Retained-...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho Clinical Diagnostics directly.
Affected Products
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Quantity: 130 units (U.S.=57; OUS=73)
Why Was This Recalled?
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report