CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent
FDA device recall Z-1000-2015 · posted 2015-01-20 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
- Action taken
- Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GKL
- Quantity affected
- 165 units
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-20
- Date terminated
- 2016-02-23
- 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 |
|---|---|---|
| ANTI-HUMAN LEU-2A (CD8) PE (K904390) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-12-17 |