Recall Z-1423-2013 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
Becton Dickinson & Co.
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
| Date | May 29, 2013 (initiated Apr 12, 13) |
| Status | Terminated |
| Reason | In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. |
| Root cause | Mixed-up of materials/components |
| Action | BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inqu |
| Quantity | 610 total test kits (PYR and Oxidase) |
| Distribution | Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896398 | DIFCO OXIDASE DRYSLIDE Difco Laboratories, Inc., Dec 18, 1989 |