Z-2378-2016Class III

BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4...

Name: Z-2378-2016 BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2016-07-18
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2016-07-18 / Terminated / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of 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... on 2016-07-18. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2378-2016
Classification: Class III
Status: Terminated
Initiated: 2016-07-18
Posted: 2016-08-09
Terminated: 2017-03-01
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2378-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2378-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-09

Product code GKZ

K071143Class IIBd Tritest Cd3/cd4/cd45, Model 340383Bd Biosciences / cleared 2007-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)