Z-0314-2017 Class II Terminated
FDA device recall Z-0314-2017 was initiated by BBI SOLUTIONS OEM LTD on June 1, 2016 and is designated Class II. Reason for recall: 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 poss… The recall status is terminated (terminated June 14, 2018). Affected quantity: 420 units (183 units quarantined).
Recall Details
- Product Type
- Devices
- Report Date
- November 2, 2016
- Initiation Date
- June 1, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units (183 units quarantined)
Product Description
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
Reason for Recall
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.
Distribution Pattern
US distribution to CT and IN
Code Information
Lot Numbers containing test reagent lot # 1012-34437): BU183A, BU183B, BU184A, BU185A, BU185B Expiration Date: 31 JUL 2016