Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tina-quant D-Dimer Test System Recalled by Roche Diagnostics Operations, Inc. Due to Elevated results were detected with Li-heparin plasma samples...
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
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Quantity: 5,263 kits
Why Was This Recalled?
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
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