Recall Z-2233-2014 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
| Date | Aug 14, 2014 (initiated Jul 18, 2014) |
| Status | Terminated |
| Reason | The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02 |
| Root cause | Labeling mix-ups |
| Action | Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem. |
| Quantity | 85 |
| Distribution | IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982231 | STATUSFLOW R&D Systems, Inc., Jul 20, 1998 |