Z-1375-2015Class II

CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

Name: Z-1375-2015 CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Creator: BD Biosciences, Systems & Reagents
Published: 2015-03-23
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-03-23 / Terminated

FDA source

BD Biosciences, Systems & Reagents began a recall of CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent on 2015-03-23. FDA classified it as Class II and gives the reason as "One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1375-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-23
Posted: 2015-04-02
Terminated: 2016-02-26
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Product code: MVU Reagents, Specific, Analyte
Reason for recall: One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.
FDA root cause: Under Investigation by firm
Action: Recall letters were sent to affected sites on March 23, 2015 by certified mail. All product in house was placed on ship hold and remaining inventory is in process of being scrapped.
Quantity in commerce: 9
Distribution: US Distribution in states of: MO, GA, AZ, NE, TX, VA
Product codes and lots: Lot 5008762, Exp 11/30/16.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1375-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-02

Product code MVU

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)