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 determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.
FDA Recall Z-2378-2016 · Posted 2016-08-09
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Recalling FirmBecton, Dickinson and Company, BD Biosciences
Recall StatusTerminated
Product CodeGKZ
Date Initiated2016-07-18
Date Terminated2017-03-01
Product Quantity14,089
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.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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