Z-1000-2015Class II

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct...

Name: Z-1000-2015 CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct...
Creator: BD Biosciences, Systems & Reagents
Published: 2014-12-19
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2014-12-19 / Terminated / root cause: manufacturing process

FDA source

BD Biosciences, Systems & Reagents began a recall of CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature... on 2014-12-19. FDA classified it as Class II and gives the reason as "One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1000-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-01-20
Terminated: 2016-02-23
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.
Quantity in commerce: 165 units
Distribution: Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
Product codes and lots: Lot number 4220622, Expiry 2016-04-30.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1000-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1000-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-20

Product code GKL

K904390Class IIAnti-Human Leu-2A (Cd8) PeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1990-12-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)