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Recall Observatory FDA recall evidence

Device product

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

Z-1390-2016

March 18, 2016

Class III

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 73597
Status
Terminated
Classification
Class III
Quantity
205
Official record key
device-enforcement:Z-1390-2016

Official wording

Reason: 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.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.