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Recall Observatory FDA recall evidence

Device product

BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

Z-2233-2014

July 18, 2014

Class III

Product summary

Firm
BD Biosciences, Systems & Reagents
Event
Event 68892
Status
Terminated
Classification
Class III
Quantity
85
Official record key
device-enforcement:Z-2233-2014

Official wording

Reason: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

Code information: Catalog number 340916; Lot number BM084L

Distribution pattern: IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    label contains the incorrect