Recall Z-0628-2016— Becton, Dickinson and Company, BD Biosciences
Class III · Terminated
Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2015-12-14, terminated 2016-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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%..
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-12-14
- Terminated
- 2016-10-31
- Firm location
- San Jose, CA, United States
Product description
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%.
Data sourced from openFDA. This site is unofficial and independent of the FDA.