Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS 3600 Immunodiagnostic System (New and Refurbished) Recalled by Ortho-Clinical Diagnostics, Inc. Due to Potential For Aspiration from Unintended Sample Container During...
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, Inc. directly.
Affected Products
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Quantity: 489 units (46 US, 443 OUS)
Why Was This Recalled?
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report