FDA-Device2016-11-02Class II
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
BBI SOLUTIONS OEM LTD
Hazard
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.
Sold states
US distribution to CT and IN
Affected count
420 units (183 units quarantined)
Manufactured in
8 Tom McDonald Avenue, Dundee, United Kingdom
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief