FDA Device recall Z-0628-2016
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent
- FDA Device
- Class III
- terminated
- Published 2016-01-20
On 2016-01-20 the FDA classified a Class III recall of FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent by Becton Dickinson And Bd Biosciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0628-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-12-14 |
| Published | 2016-01-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
Product
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Reason
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%.
Identifiers
| code_info | Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0628-2016%22
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