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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Scientific VersaTREK REDOX 1, Ref 710244

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  Class 2 Device Recall Thermo Scientific VersaTREK REDOX 1, Ref 710244 see related information
Date Initiated by Firm June 11, 2014
Date Posted July 15, 2014
Recall Status1 Terminated 3 on August 28, 2014
Recall Number Z-2057-2014
Recall Event ID 68583
510(K)Number K032306  
Product Classification System, blood culturing - Product Code MDB
Product Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Code Information Segments 1, 5, and 6 only of Lot 492571, Exp. 2015-10
Recalling Firm/
Manufacturer		 Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact Earleen C. Parks
913-895-4185
Manufacturer Reason
for Recall		 Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
FDA Determined
Cause 2		 Employee error
Action The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
Quantity in Commerce 76/50-bottle boxes
Distribution Distribution was made to CO, IL, IN, NE, NJ, PA, SD, and a government facility located in VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MDB and Original Applicant = TREK DIAGNOSTIC SYSTEMS, INC.
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