Device product
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Z-1422-2013
Product summary
- Event
- Event 65089
- Status
- Terminated
- Classification
- Class II
- Quantity
- 610 total test kits (PYR and Oxidase)
- Official record key
device-enforcement:Z-1422-2013
Official wording
Reason: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Code information: PYR kit - lot 2276481 with expiration date 09/30/13
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