PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 2, 2015 Initiated: July 17, 2015 #Z-2453-2015

Product Description

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.

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.

Details

Units Affected
362 units
Distribution
US Distribution and Internationally to Taiwan.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 362 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2453-2015.