Recall Z-0171-2016— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-0171-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-30

Class III · Terminated

Class III FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2015-09-30, terminated 2016-10-18. It names one FDA 510(k) clearance: K842218. Product: 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.. Reason: Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class III
Status: Terminated
Initiated: 2015-09-30
Terminated: 2016-10-18
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K842218 — ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1984-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.

Data sourced from openFDA. This site is unofficial and independent of the FDA.