Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SimpliRED D-Dimer Recalled by BBI SOLUTIONS OEM LTD Due to A component of the kit is showing a...
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 BBI SOLUTIONS OEM LTD directly.
Affected Products
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
Quantity: 420 units (183 units quarantined)
Why Was This Recalled?
A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.
Where Was This Sold?
This product was distributed to 2 states: CT, IN
About BBI SOLUTIONS OEM LTD
BBI SOLUTIONS OEM LTD has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report