FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

FDA device recall Z-0628-2016 · posted 2016-01-11 · Terminated

Recall details

Recalling firm

Becton, Dickinson and Company, BD Biosciences

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%.

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MVU

Quantity affected

1,388 units

Distribution

Nationwide Distribution

Date initiated

2015-12-14

Date posted

2016-01-11

Date terminated

2016-10-31

Location

San Jose, CA