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Recall Observatory FDA recall evidence

Device 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.

Z-2453-2015

July 17, 2015

Class II

Product summary

Firm
Becton, Dickinson and Company, BD Biosciences
Event
Event 71826
Status
Terminated
Classification
Class II
Quantity
362 units
Official record key
device-enforcement:Z-2453-2015

Official wording

Reason: 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.

Code information: Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015

Distribution pattern: US Distribution and Internationally to Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.