Recall Z-2041-2014 ยท JSS Kit, Identification, Enterobacteriaceae
Becton Dickinson & Co.
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.
| Date | Jul 11, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | BD Diagnostic sent an Urgent Product Recall letter dated May 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please discard any outer kit boxes that are labeled with the incorrect expiration date. All components of the kit will perform as expected with the expiration dates on each component. Our records indicate you may have been shipped a portion of the above-referenced product between August 23, 2013, and the present day. Please complete the attached form whether or not you |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926018 | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM Becton Dickinson Microbiology Systems, Mar 11, 1993 |