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
Product summary
- 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
label contains the incorrect