VIDAS D-Dimer Exclusion II — Class II medical device recall Z-2232-2014
Terminated recall by BioMerieux SA, reported 2014-08-20, distributed in AL, AR, CA, CO, CT, DE, FL, GA…. Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negati
| Recall number | Z-2232-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2013-04-17 |
| Classified | 2014-08-14 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2014-10-08 |
| Distributed | 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 |
| Quantity | 2,160 units |
| Lot numbers | 1001625210, 1001711530, 1001715580, 1001789540, 1001932680, 8/8/20123 |
| Expiration dates | 2013-09-11, 2013-09-26, 2013-10-29, 2013-12-12 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2232-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.