Device recall: VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzy

Q: Why was this device recalled?

FDA's record gives the reason for recall 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 <45 ng/mL."

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "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"

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 8 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 68747 · Class II · initiated 17 Apr 2013 · status Terminated · terminated 8 Oct 2014

DeviceVoluntary: Firm initiated1 product recordMarcy L'Etoile, N/A

FDA enforcement event 68747 is a device recall by BioMerieux SA of Marcy L'Etoile, N/A, initiated 17 Apr 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 8 Oct 2014. Initiation: voluntary: firm initiated. BioMerieux SA has 21 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

BioMerieux SA, Marcy L'Etoile, N/A, France.

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."

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 records

Recall number	Product	Quantity	Class	Status	Report date
Z-2232-2014	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…	2160 units	Class II	Terminated	20 Aug 2014

Context

90%of 2013 device events are Class II1,236 events that year

1product record in this eventfirm median: 1

21events on this register for the firm

Other enforcement events for BioMerieux SA

Initiated	Product (first record)	Type	Class	Records
2 Sep 2021	MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System	Device	Class II	1
22 Jun 2021	MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results b	Device	Class II	1
17 Sep 2018	NucliSENS¿ Magnetic Extraction Reagents	Device	Class II	1
9 Apr 2018	VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the	Device	Class II	1
23 Mar 2018	The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identi	Device	Class II	9
18 Oct 2017	NucliSENS Lysis Buffer Extended lot for RES 76675	Device	Class II	1
25 Apr 2017	ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the ant	Device	Class II	1
13 Apr 2017	ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptib	Device	Class II	2
17 Mar 2017	VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments o	Device	Class II	1
7 Mar 2017	NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid fr	Device	Class II	1

All 21 events for BioMerieux SA

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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 <45 ng/mL."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 8 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.