Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 5 Recalled by Ortho Clinical Diagnostics Due to Potential Unsuccessful Calibration Due to Software Anomaly in...
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 5,1 FS Chemistry System, clinical chemistry analyzer
Quantity: 1051
Why Was This Recalled?
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
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