FDAClass IIIApril 20, 2016

BD-Retic-Count Reticulocyte Reagent System recall

BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics

Why was BD-Retic-Count Reticulocyte Reagent System recalled?

The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct.

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?

Product number 349214, Lot number 5175559, Expiry 5/31/16.

Product
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
205
Distribution
Worldwide Distribution - US Distribution to the states of : CT, MN, FL, NY, CA, MA, DC, UT, VA and IN., and to the countries of : Belgium, Brazil, Canada, China, India, Japan, Korea, Singapore and Taiwan.
Recall date
April 20, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls