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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
Recalled November 2, 2016 · FDA recall Z-0314-2017 · BBI SOLUTIONS OEM
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. · FDA Class II
Units
420 units (183 units quarantined)
Sold at
US distribution to CT and IN
Description
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.
Product
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
Manufacturer(s)
BBI SOLUTIONS OEM LTD
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →