Recall Z-2232-2014 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
BioMerieux SA
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.
| Date | Aug 14, 2014 (initiated Apr 17, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112818 | VIDAS D-DIMER EXCLUSION II (DEX2) bioMerieux, Inc., Jul 31, 2012 |