SimpliRED D-Dimer — Class II medical device recall Z-0314-2017
Terminated recall by BBI SOLUTIONS OEM LTD, reported 2016-11-02, distributed in CT, IN. A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 1
| Recall number | Z-0314-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BBI SOLUTIONS OEM LTD, Dundee, United Kingdom |
| Recall initiated | 2016-06-01 |
| Classified | 2016-10-27 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2018-06-14 |
| Distributed | CT, IN |
| Reason classes | specification failure |
| Lot numbers | 1012-34437 |
| Expiration dates | 2016-07-31 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0314-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.