PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: November 4, 2015 Initiated: September 30, 2015 #Z-0171-2016

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.

Details

Units Affected
120 units
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.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton, Dickinson and Company, BD Biosciences. Units affected: 120 units.
Why was this product recalled?
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 4, 2015. Severity: Low. Recall number: Z-0171-2016.