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U.S. Department of Health and Human Services

Class 2 Device Recall Streptex Latex D, Ref R30950901 ZL54

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 Class 2 Recall
Streptex Latex D, Ref R30950901 ZL54
see related information
Date Posted December 18, 2013
Recall Status1 Terminated on March 12, 2014
Recall Number Z-0538-2014
Recall Event ID 65476
Premarket Notification
510(K) Number
K842828 
Product Classification Discs, Strips And Reagents, Microorganism Differentiation - Product Code JTO
Product Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
Code Information Lot 1149576, exp January 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 product may give weak or false negative test results.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
Quantity in Commerce 109 kits
Distribution Nationwide Distribution
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 = JTO and Original Applicant = WELLCOME DIAGNOSTICS
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