Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 3600 Immunodiagnostic System Recalled by Ortho-Clinical Diagnostics Due to Software Anomaly: the firm has identified an anomaly...
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 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Quantity: 658 total: USA - 144, Foreign - 514
Why Was This Recalled?
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report