FDAClass IIIJanuary 20, 2016

Fmc7 Fitc recall: Impurity Out of Spec

FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

Why was Fmc7 Fitc recalled?

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%.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
1,388 units
Distribution
Nationwide Distribution
Recall date
January 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls