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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- 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
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