Z-2233-2014Class III

BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for...

Name: Z-2233-2014 BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for...
Creator: BD Biosciences, Systems & Reagents
Published: 2014-07-18
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2014-07-18 / Terminated / root cause: labeling and UDI

FDA source

BD Biosciences, Systems & Reagents began a recall of BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry on 2014-07-18. FDA classified it as Class III and gives the reason as "The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02". 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-2233-2014
Classification: Class III
Status: Terminated
Initiated: 2014-07-18
Posted: 2014-08-14
Terminated: 2015-05-19
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Product code: GKZ Counter, Differential Cell
Reason for recall: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.
Quantity in commerce: 85
Distribution: IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium
Product codes and lots: Catalog number 340916; Lot number BM084L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2233-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2233-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code GKZ

K982231Class IIStatusflowR&D Systems, Inc. / cleared 1998-07-20

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)