RecallDepth

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

Company
Becton, Dickinson And Company, Bd Biosciences
Recall Initiated
December 14, 2015
Posted
January 11, 2016
Terminated
October 31, 2016
Recall Number
Z-0628-2016
Quantity
1,388 units
Firm Location
San Jose, CA

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%.

Distribution

Nationwide Distribution

Lot / Code Info

Lot No. 4162520, 4206855, 4267919, 4276818, 4309977, 5009530, 5036624, 5085573, 5182818

Root Cause

Under Investigation by firm

Action Taken

BD Biosciences sent an Urgent Product Recall letter dated December 2015, to all affected customers to inform them that Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return the Tracking/Verification form to BD Biosciences. Customers are instructed to contact BD Customer Support at (877) 232-8995 (prompt 3, 3) in the US. Customers outside of the US are instructed to contact their local BD Biosciences or distributor.

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