Z-2232-2014Class II

VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the...

Name: Z-2232-2014 VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the...
Creator: BioMerieux SA
Published: 2013-04-17
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-04-17 / Terminated

FDA source

BioMerieux SA began a recall of VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin... on 2013-04-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2232-2014
Classification: Class II
Status: Terminated
Initiated: 2013-04-17
Posted: 2014-08-14
Terminated: 2014-10-08
Recalling firm: bioMerieux, Inc.
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.
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 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 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2232-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2232-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code DAP

K112818Class IIVidas D-Dimer Exclusion II (Dex2)bioMerieux, Inc. / cleared 2012-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)