PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: April 20, 2016 Initiated: March 18, 2016 #Z-1390-2016

Product Description

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

Reason for Recall

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.

Details

Units Affected
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.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 205.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 20, 2016. Severity: Low. Recall number: Z-1390-2016.