The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2041-2014·Announced 2014-07-23

BBL CrystaLEAD E/NF Identification Kits Recalled for Incorrect Expiration Dates

Becton Dickinson is recalling specific lots of BBL CrystaLEAD E/NF Identification kits because some contain fluid bottles that expire before the date printed on the kit carton.

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. The issue is a labeling discrepancy regarding expiration dates, which falls under the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Becton Dickinson & Co. is recalling a portion of the BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. This in vitro diagnostic is used for the identification of aerobic gram-negative bacteria, including those in the family Enterobacteriaceae and some glucose fermenting and nonfermenting gram-negative bacilli.

The recall affects lot numbers 3224281 and 3290379. The issue is that a portion of these kits are labeled with incorrect expiration dates on the kit carton. Specifically, some kits contain Crystal Inoculum fluid bottles that will expire prior to the date printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.

The affected products were distributed worldwide, including in the United States, Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan. Users should check their inventory for these specific lot numbers and verify the expiration dates on the individual fluid bottles against the kit carton.

The recalled product

Product
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose…
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — In Vitro Diagnostics
Hazard

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 (2)

  • Lot. Number - 3224281 / Exp. Date - 2014/06/09
  • Lot. Number - 3290379 / Exp. Date - 2014/07/24

Distribution

Distributed nationwide across the United States.

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