Z-1390-2016Class III

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

Name: Z-1390-2016 BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-03-18
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-03-18 / Terminated / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics on 2016-03-18. FDA classified it as Class III and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1390-2016
Classification: Class III
Status: Terminated
Initiated: 2016-03-18
Posted: 2016-04-14
Terminated: 2016-12-02
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Product code: GKL Counter, Cell, Automated (Particle Counter)
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: BD Biosciences sent an Urgent Product Recall letter on March 18, 2016, to all affected customers by certified mail. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Examine your data files obtained using reagents from the affected lots for low performance. 2. Discard all remaining stock of BD Retic-Counter reticulocyte reagent system, Catalog Number 349204, lot number 5175559, and request replacement product. BD will replace product at no cost. 3. As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking/Verification form , even if you no longer have the affected reagents listed in your inventory. Please return the Tracking/Verification form to BD Biosciences, per the instructions (mail, fax, or email). If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in commerce: 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.
Product codes and lots: Product number 349214, Lot number 5175559, Expiry 5/31/16.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2016	Class III	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code GKL

K880636Class IIReticcount SoftwareBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1988-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)