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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00599-1
Product Name/Description BBL Crystal Enteric/Nonfermenter ID Kit. An in vitro diagnostic medical device (IVD).

Catalogue Number: 245000

Lot Numbers: 3224281 & 3290379

ARTG Number: 195682
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/05/2014
Responsible Entity Becton Dickinson Pty Ltd
Reason/Issue BD has determined that the Crystal Inoculum fluid within the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from the referenced lots are labelled with incorrect expiration dates. The Crystal Inoculum fluid bottles 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.
Recall Action Recall for Product Correction
Recall Action Instructions BD is requesting their customers to discard the outer boxes that are labelled with the incorrect expiration date.
Contact Information 02 8875 7201 - BD Regulatory Affairs