Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas HCYS Recalled by Roche Diagnostics Operations, Inc. Due to Abnormal calibration signals and control recovery issues on...
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
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Quantity: 458 units
Why Was This Recalled?
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Where Was This Sold?
This product was distributed to 8 states: FL, IN, IA, NJ, NY, OK, SC, TX
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