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

BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The… — recall Z-0171-2016

U.S. FDA — Device Enforcement · United States · 2015-09-30 · Class III

As described by U.S. FDA — Device Enforcement: BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0171-2016
Date of alert
2015-09-30
Country / jurisdiction
United States
Risk level
Class III
Notice type
recall
Brand
Becton, Dickinson and Company, BD Biosciences
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.
Reported risk: Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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