FDAFDA · Food and drugs·Recall number Z-0530-2014
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.
Published December 25, 2013 · Recall initiated: April 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- 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.
- Lot
- Lot 302532, Exp 6 Feb 2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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