Device 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
Z-0314-2017
Product summary
- Event
- Event 74786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 420 units (183 units quarantined)
- Official record key
device-enforcement:Z-0314-2017
Official wording
Reason: 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.
Code information: Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016
Distribution pattern: US distribution to CT and IN
Derived failure modes
-
Unknown
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.