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BBI SOLUTIONS OEM Recalls

1 recall on record · November 2, 2016 to November 2, 2016 · Medical Devices

November 2, 2016Medical DevicesFDA

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

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.

BBI SOLUTIONS OEM Recalls | RecallWatchUSA