FDAFDA · Food and drugs·Recall number Z-2232-2014
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.
Published August 20, 2014 · Recall initiated: April 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- 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
- Lot
- Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11/2013; 1001789540, Exp. date 10/29/2013; 1001932680, Exp. date 12/12/2013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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