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Class 2 Device Recall Streptex Latex D, Ref R30950901 ZL54 |
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Date Initiated by Firm |
May 02, 2013 |
Date Posted |
December 18, 2013 |
Recall Status1 |
Terminated 3 on March 12, 2014 |
Recall Number |
Z-0538-2014 |
Recall Event ID |
65476 |
510(K)Number |
K842828
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Product Classification |
Discs, strips and reagents, microorganism differentiation - Product Code JTO
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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 KS 66215-3519
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For Additional Information Contact |
Earleen C. Parks 913-888-0939
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Manufacturer Reason for Recall |
The product may give weak or false negative test results.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JTO and Original Applicant = WELLCOME DIAGNOSTICS
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