BD Tritest CD3 FITC/CD4 PE/CD45 PerCP — Class III medical device recall Z-2378-2016
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-08-17, distributed nationwide. Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product doe
| Recall number | Z-2378-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2016-07-18 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2017-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 14,089 |
| Lot numbers | 01810, 15614, 36715, 49983, 54689, 57797, 82527 |
| Model numbers | 340383 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2378-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.