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FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.

FDA Recall #Z-0628-2016 — Class III — December 14, 2015

Recall #Z-0628-2016 Date: December 14, 2015 Classification: Class III Status: Terminated

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%.

Recalling Firm

Becton, Dickinson and Company, BD Biosciences — San Jose, CA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

1,388 units

Distribution

Nationwide Distribution

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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