Recall Z-0314-2017 ยท GHH Fibrin Split Products
BBI SOLUTIONS OEM LTD
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
| Date | Jun 1, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | BBI Solutions sent an Urgent Medical Device Recall letter dated June 30, 2016, to all affected customers. Customers were advised to immediately discontinue use of the product, consider the requirement for review of reported test results, complete and return the customer acknowledgement form to BBI Solutions and to complete and return the customer reconciliation form to the distributor. Customers who have forwarded product to other sites, should inform those customers of the product recall and provide them with a copy of the notice. Customers with questions were instructed to call Tel: +44 |
| Quantity | 420 units (183 units quarantined) |
| Distribution | US distribution to CT and IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY Agen Biomedical , Ltd., Apr 12, 1991 |