The Recall Desk
LowFDA (Devices)·Z-1390-2016·Announced 2016-04-20

BD Retic-Count Reagent System Recalled for Incorrect Storage Labeling

Becton, Dickinson and Company is recalling one lot of BD Retic-Count Reticulocyte Reagent System because the carton label listed incorrect storage conditions.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging/labeling error regarding storage conditions, which fits the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 205 units of the BD-Retic-Count Reticulocyte Reagent System, product number 349214, lot number 5175559. This hematology reagent is used for in vitro diagnostics. The recall is limited to the specific lot with an expiry date of 5/31/16.

The recall was initiated because the carton label for this specific lot displayed incorrect storage conditions. The source text confirms that the labels on the reagent itself and the Instructions for Use are correct. The product was distributed worldwide, including to specific US states and international countries.

No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare facilities should check their inventory for the specific lot number and product number listed above. If the product is found, it should be returned to the supplier or the manufacturer for credit.

The recalled product

Product
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
Affected units
205

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 10 states: