CLASS III Device recall · Reported 20 Apr 2016 · FDA Enforcement Report

BD-Retic-Count Reticulocyte Reagent System recalled

Becton, Dickinson and Company, BD Biosciences is recalling BD-Retic-Count Reticulocyte Reagent System, distributed in 10 states. The recall was initiated on 18 Mar 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesProduct number 349214, Lot number 5175559, Expiry 5/31/16.

Quantity recalled205

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1390-2016
FDA event ID: 73597
Recalling firm: Becton, Dickinson and Company, BD Biosciences, San Jose, CA
Classification: Class III
Status: Terminated
Recall initiated: 18 Mar 2016
FDA classified: 14 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

18 Mar 2016	Recall initiated by company
14 Apr 2016	Classified by FDA	+27 days
20 Apr 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

California Connecticut District of Columbia Florida Indiana Massachusetts Minnesota New York Utah Virginia

Questions about this recall

Is BD-Retic-Count Reticulocyte Reagent System recalled?

Yes. Becton, Dickinson and Company, BD Biosciences recalled BD-Retic-Count Reticulocyte Reagent System on 18 Mar 2016. The recall is Class III and its status is Terminated. Recall number Z-1390-2016.

Why was it 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 lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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