BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flo
FDA device recall Z-2233-2014 · posted 2014-08-14 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
- Action taken
- Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 85
- Distribution
- IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium
- Date initiated
- 2014-07-18
- Date posted
- 2014-08-14
- Date terminated
- 2015-05-19
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STATUSFLOW (K982231) | R&D Systems, Inc. | 1998-07-20 |