FDA Device recall Z-2378-2016
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD)
- FDA Device
- Class III
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class III recall of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD) by Becton Dickinson And Bd Biosciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2378-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-07-18 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527…Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2378-2016%22
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