Device product
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
Z-1423-2013
Product summary
- Event
- Event 65089
- Status
- Terminated
- Classification
- Class II
- Quantity
- 610 total test kits (PYR and Oxidase)
- Official record key
device-enforcement:Z-1423-2013
Official wording
Reason: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Code information: Oxidase kit - lot 2222008 with expiration date 08/31/13
Distribution pattern: Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Derived failure modes
-
Labeling or packaging
incorrect packaging