Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2453-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-07-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2453-2015
Date of alert: 2015-07-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Becton, Dickinson and Company, BD Biosciences
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2453-2015 — 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.

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