FDAClass IIIJuly 23, 2014

BBL CrystaLEAD Enteric/Nonfermentor recall

BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic…

Why was BBL CrystaLEAD Enteric/Nonfermentor recalled?

A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates. A portion of these kits contain Crystal Inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. The expiration date printed on the individual Crystal Inoculum fluid bottles is correct.

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?

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

Product
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic…
Recalling firm
Becton Dickinson & Co.
Quantity
18.210
Distribution
Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
Recall date
July 23, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls