Recall Z-1390-2016— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-1390-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-18

Class III · Terminated

Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-03-18, terminated 2016-12-02. It names one FDA 510(k) clearance: K880636. 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..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class III
Status: Terminated
Initiated: 2016-03-18
Terminated: 2016-12-02
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K880636 — RETICCOUNT SOFTWAREBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1988-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.