FDAClass IIISeptember 30, 2015

CD4 (SK3) recall

CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3…

Why was CD4 (SK3) recalled?

CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.

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 340133; lot # 5112711, Expiration date: 30 Nov 2016.

Product
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3…
Recalling firm
Becton, Dickinson and Company, BD Biosciences
Quantity
128 units
Distribution
Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.
Recall date
September 30, 2015
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls