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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Event Detail

Event ID 65477
Product Type Devices
Status Completed
Recalling Firm Remel Inc
City Lenexa
State KS
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot 302532, Exp 6 Feb 2014 Class II The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed. 150 kits Z-0530-2014
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