CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in
FDA device recall Z-2817-2015 · posted 2015-09-24 · Terminated
Recall details
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Reason for recall
- CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
- Action taken
- Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 128 units
- Distribution
- Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.
- Date initiated
- 2015-08-27
- Date posted
- 2015-09-24
- Date terminated
- 2016-08-09
- 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-3A (CD4) FITC (K900802) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-05-15 |