FDAClass IIINovember 4, 2015

BD CD3 recall

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…

Why was BD CD3 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)

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…
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
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.
Recall date
November 4, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls