Reported Aug 20, 2014 · Terminated
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the…
BioMerieux SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Reference 304551-01 - Lots 1001625210Exp. date 8/8/201231001715580Exp. date 9/26/20131001711530Exp. date 9/11/20131001789540Exp. date 10/29/20131001932680Exp. date 12/12/2013
- Amount recalled
- 2160 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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