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U.S. Department of Health and Human Services

Class 2 Device Recall remel RapID Yeast Plus System

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 Class 2 Recall
remel RapID Yeast Plus System
see related information
Date Posted December 17, 2013
Recall Status1 Terminated on March 12, 2014
Recall Number Z-0530-2014
Recall Event ID 65477
Premarket Notification
510(K) Number
K943621 
Product Classification Kit, Identification, Yeast - Product Code JXB
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.
Code Information Lot 302532, Exp 6 Feb 2014
Recalling Firm/
Manufacturer
Remel Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519
For Additional Information Contact Earleen C. Parks
913-888-0939
Manufacturer Reason
for Recall
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Thermo Fisher Scientific sent a Medical Device Recall letter dated April 3, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm instructed customer to review their inventory for affected lot and discard the product. A Medical Device Recall Return Response was enclosed for the customer to indicate they understood the instructions and to report the amount of product they discarded. For questions call Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in Commerce 150 kits
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JXB and Original Applicant = INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
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