Food, drugs, devices › Becton, Dickinson and Company, BD Biosciences
Device recall: BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Becton, Dickinson and Company, BD Biosciences (San Jose, CA) initiated this device recall on 18 Mar 2016; FDA lists 1 product record under event 73597, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 2 Dec 2016. Initiation: voluntary: firm initiated. Becton, Dickinson and Company, BD Biosciences has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Becton, Dickinson and Company, BD Biosciences, San Jose, CA.
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."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1390-2016 | BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics | 205 | Class III | Terminated | 20 Apr 2016 |
Context
Other enforcement events for Becton, Dickinson and Company, BD Biosciences
All 22 events for Becton, Dickinson and Company, BD Biosciences
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 2 Dec 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.