Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Recalled by Roche Diagnostics Operations, Inc. Due to Inaccurately Low Sample Results
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 Roche Diagnostics Operations, Inc. directly.
Affected Products
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Quantity: 33979 units
Why Was This Recalled?
Inaccurately Low Sample Results
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Diagnostics Operations, Inc.
Roche Diagnostics Operations, Inc. has 127 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report