RecallRadar

FDA Device recall Z-1390-2016

BD-Retic-Count Reticulocyte Reagent System

On 2016-04-20 the FDA classified a Class III recall of BD-Retic-Count Reticulocyte Reagent System by Becton Dickinson And Bd Biosciences, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1390-2016
ClassificationClass III
Statusterminated
Initiated2016-03-18
Published2016-04-20
Last updated2026-09-13 11:54 UTC
CompanyBecton Dickinson And Bd Biosciences
DistributionCA, CT, DC, FL, IN, MA, MN, NY, UT, VA

Product

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

Reason

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2016%22

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