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 |
|
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 |