Reported Nov 2, 2016 · Terminated
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of…
Bbi Solutions Oem Ltd.
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: BBI SOLUTIONS OEM LTD · 8 Tom McDonald Avenue · Dundee · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A
- BU185B Expiration Date31 JUL 2016
- Amount recalled
- 420 units (183 units quarantined)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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