FMC7 FITC — Class III medical device recall Z-0628-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-01-20, distributed nationwide. Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradatio
| Recall number | Z-0628-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2015-12-14 |
| Classified | 2016-01-11 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-10-31 |
| Distributed | Nationwide (US) |
| Quantity | 1,388 units |
| Reason classes | specification failure |
| Lot numbers | 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818 |
| Model numbers | 340918 |
Product
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Reason for recall
Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%.
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-0628-2016. 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.