Z-2817-2015Class III

CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro...

Name: Z-2817-2015 CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2015-08-27
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-08-27 / Terminated / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal... on 2015-08-27. FDA classified it as Class III and gives the reason as "CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC". 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-2817-2015
Classification: Class III
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-09-24
Terminated: 2016-08-09
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
Product code: GKZ Counter, Differential Cell
Reason for recall: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.
Quantity in commerce: 128 units
Distribution: Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.
Product codes and lots: Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2817-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2817-2015	Class III	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-24

Product code GKZ

K900802Class IIAnti-Human Leu-3A (Cd4) FitcBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1990-05-15

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)