Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VIDAS D-Dimer Exclusion II Recalled by BioMerieux SA Due to Customer complaints about not repeatable results below the...
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 BioMerieux SA directly.
Affected Products
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.
Quantity: 2160 units
Why Was This Recalled?
Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.
Where Was This Sold?
This product was distributed to 40 states: AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY
About BioMerieux SA
BioMerieux SA has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report