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Recall Observatory FDA recall evidence

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

April 04, 2013

Class II

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

    reason.labeling_packaging · v1.0.0

    mislabeled