Class II — BBI SOLUTIONS OEM LTD
| Recalling firm | BBI Solutions OEM Limited |
|---|---|
| Registered facility | BBI SOLUTIONS OEM LIMITED (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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 |
| Quantity | 420 units (183 units quarantined) |
| Distribution | US distribution to CT and IN |
| Initiated | 2016-06-01 |
| Classified | 2016-10-27 |
| Terminated | 2018-06-14 |
| Recall number | Z-0314-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BBI SOLUTIONS OEM LTD (Z-0314-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74786/
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