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Recall Observatory FDA recall evidence

Device product

BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.

Z-0851-2016

January 25, 2016

Class III

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 73155
Status
Terminated
Classification
Class III
Quantity
78
Official record key
device-enforcement:Z-0851-2016

Official wording

Reason: Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label.

Code information: Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16.

Distribution pattern: Worldwide Distribution - US Nationwide in the staates of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK. and coutry of Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label.