openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
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FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
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%.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
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%.
