BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP w
FDA device recall Z-2378-2016 · posted 2016-08-09 · Terminated
Recall details
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Reason for recall
- Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.
- Action taken
- BD Life Sciences sent an Urgent Product notification letter dated July 18, 2016 to all affected customers via UPS and/or e-mail. The letter informed the user of the issue and states that no action is required since product performance is not impacted. The response form is to be returned to BD as instructed. Customers requiring further assistance were instructed to contact BD Customer Support at 855-236-2772. For questions regarding this recall call 408-954-6080.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 14,089
- Distribution
- Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
- Date initiated
- 2016-07-18
- Date posted
- 2016-08-09
- Date terminated
- 2017-03-01
- 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 |
|---|---|---|
| BD TRITEST CD3/CD4/CD45, MODEL 340383 (K071143) | Bd Biosciences | 2007-06-06 |