BBI SOLUTIONS OEM LTD recalls SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cro…

Recall date

June 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0314-2017

FDA classification

Class II

Brand / firm

BBI SOLUTIONS OEM LTD

Sold / distributed

US distribution to CT and IN

Why it was recalled

A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negative results are possible which may incorrectly influence the clinical diagnostic decision.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood