Recall Z-2378-2016 ยท GKZ Counter, Differential Cell
Becton, Dickinson and Company, BD Biosciences
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and d
| Date | Aug 9, 2016 (initiated Jul 18, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 Bd Biosciences, Jun 6, 2007 |