FDA Device recall Z-2232-2014
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination…
- FDA Device
- Class II
- terminated
- Published 2014-08-20
On 2014-08-20 the FDA classified a Class II recall of VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination… by Biomerieux, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2232-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-17 |
| Published | 2014-08-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY |
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.
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.
Identifiers
| code_info | Reference 304551-01 - Lots 1001625210, Exp. date 8/8/20123; 1001715580, Exp. date 9/26/2013; 1001711530, Exp. date 9/11…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2232-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.