Device 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 fermenting and nonfermenting gram-negative bacilli.
Z-2041-2014
Product summary
- Event
- Event 68468
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18.210
- Official record key
device-enforcement:Z-2041-2014
Official wording
Reason: 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.
Code information: Lot. Number - 3224281 / Exp. Date - 2014/06/09 , Lot. Number - 3290379 / Exp. Date - 2014/07/24, Lot. Number - 3224281 / Exp. Date - 2014/06/09
Distribution pattern: Worldwide Distribution - US (nationwide), Australia, Belgium, Canada, Colombia, China, Indonesia, India, Japan, Korea, Mexico, Malaysia, Peru, Philippines, Singapore, Thailand, and Taiwan.
Derived failure modes
-
Unknown
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.