Agency classClass IIIOur severity:Low FDA (Devices)·Z-2817-2015·Announced 2015-09-30

BD Biosciences Recalls CD4 FITC Reagent Due to Spanish Labeling Error

Becton, Dickinson and Company is recalling 128 units of CD4 (SK3), FITC reagent because the Spanish text on the label incorrectly identifies the product as CD8 FITC.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 128 units of CD4 (SK3), FITC in vitro diagnostic reagent. The product is used in hematology to detect human CD4, a cell surface receptor expressed by thymocytes and T helper cells. The recall is due to a labeling error in the Spanish small text, which incorrectly states the product is CD8 FITC.

The affected product is identified by Catalog Number 340133 and Lot # 5112711, with an expiration date of November 30, 2016. The reagent contains CD4 FITC with gelatin and 0.1% sodium Azide. The agency classifies this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.

The product was distributed worldwide, including in the United States (TX, CA, NC, OH, SD, PA, CT, UT, MD, GA) and internationally in Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile, and Colombia. Users of the product should stop using the affected units and contact the manufacturer for instructions on return or replacement.

The recalled product

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 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of…
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
Affected units: 128

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Catalog Number 340133
lot # 5112711
Expiration date: 30 Nov 2016.

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

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