Device product
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
Z-0530-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 65477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 kits
- Official record key
device-enforcement:Z-0530-2014
Official wording
Reason: The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Code information: Lot 302532, Exp 6 Feb 2014
Distribution pattern: Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CT, FL, ID, IN, KY, MA, MI, MS, NJ, OH, PA, TX, WI and the countries of Canada, UK, and Japan.
Derived failure modes
-
Labeling or packaging
mislabeled