Z-2453-2015Class II

BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen...

Name: Z-2453-2015 BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen...
Creator: Becton, Dickinson and Company, BD Biosciences
Published: 2015-07-17
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2015-07-17 / Terminated / root cause: manufacturing process

FDA source

Becton, Dickinson and Company, BD Biosciences began a recall of BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be... on 2015-07-17. FDA classified it as Class II and gives the reason as "Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern". 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-2453-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Posted: 2015-08-24
Terminated: 2016-03-11
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD Bioscience sent an Urgent Product Recall Letter dated July 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions : 1. If you have CD56 PE-Cy7 integrated into a Laboratory Developed Test (LDT) or panel, evaluate the impact of a false positive in the PE channel the interpretation of on the results. 2. Discard all remaining stock of CD56 PE-Cy7, Catalog Number 335809, lot number 4300708, 4304864, and/or 5013643, and request replacement product. BD will replace product at no cost. 3. As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking/Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking/ Verification form to BD Biosciences, per the instructions (mail, fax, or email). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.
Quantity in commerce: 362 units
Distribution: US Distribution and Internationally to Taiwan.
Product codes and lots: Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2453-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2453-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-24

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)