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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS DDimer Exclusion II

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 Class 2 Recall
VIDAS DDimer Exclusion II
see related information
Date Posted August 14, 2014
Recall Status1 Open
Recall Number Z-2232-2014
Recall Event ID 68747
Premarket Notification
510(K) Number
K112818 
Product Classification Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile
For Additional Information Contact Alan Bergold, PhD
919-620-2000
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action A recall letter was issued on 4/17/2013 to US customers via FED Ex mailing. The letter included a fax back acknowledgment form. A recall notice was also sent via email to bioMerieux Subsidiaries and international distributors on 4/11/2013.
Quantity in Commerce 2160 units
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DAP and Original Applicant = BIOMERIEUX, INC.
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