Recall Z-0699-2013 ยท JSS Kit, Identification, Enterobacteriaceae
Becton Dickinson & Co.
Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose f
| Date | Jan 20, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification. |
| Root cause | Mixed-up of materials/components |
| Action | Becton Dickinson initiated the recall by letter to direct accounts on 12/13/2012. Ex-US BD sites were notified via email, distributors were notified by fax and customer letters were delivered by UPS ground. The notification advised that the recalled kit contained citrate (CIT} and malonic acid (MLO} reagents in the reversed prong/well positions. Customers were advised to discontinue use of identified lot numbers and discard any remaining packages for replacements, and also to return the enclosed reply form. The recalling firm requested distributors to submit their customer list for direct BD n |
| Quantity | 67,820 units |
| Distribution | Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Colombia, Chile, Canada, India, Japan, Brazil, China and Belgium. |
| 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 |