Agency classClass IIIOur severity:Low FDA (Devices)·Z-2378-2016·Announced 2016-08-17

BD Tritest CD3/CD4/CD45 Reagent Recalled for Incorrect Labeling

Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.

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 indicates a violation of labeling or FDA regulations that is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the buffer content.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD), catalog number 340383. The recall was initiated after an internal review determined that the product label incorrectly states that the vials contain gelatin. The product does not contain gelatin; the label should state that it contains buffer.

The affected lots have expiration dates ranging from July 2016 to February 2017. The products were distributed nationwide to laboratories in Arkansas, California, Colorado, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, and Washington.

Healthcare facilities and laboratories should stop using the affected products and contact Becton, Dickinson and Company for instructions on returning the items. This recall addresses a labeling error regarding the buffer composition of the reagent.

The recalled product

Product: BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll…
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 14,089

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 (14)

Catalog number: 340383
lot No. Expiration Date 49983
31 July 2016
01810
30 September 2016
82527
54689
30 November 2016
36715
31 December 2016
15614
31 January 2017
57797
28 February 2017.

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

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