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Terminated

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

FDA Recall Z-0628-2016 · Posted 2016-01-11

Recalling FirmBecton, Dickinson and Company, BD Biosciences
Recall StatusTerminated
Product CodeMVU
Date Initiated2015-12-14
Date Terminated2016-10-31
Product Quantity1,388 units

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%.

Firm Action

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

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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