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U.S. Department of Health and Human Services

Class 3 Device Recall MedTest DX Assayed Human Multi Sera Control

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  Class 3 Device Recall MedTest DX Assayed Human Multi Sera Control see related information
Date Initiated by Firm October 23, 2014
Create Date June 08, 2017
Recall Status1 Terminated 3 on November 17, 2017
Recall Number Z-2316-2017
Recall Event ID 77062
510(K)Number K942458  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200)

HEC200
" Sml amber glass vial with rubber stopper and black plastic screw cap.
" 1 0 control vials per box, 12 cell foam insert.
HNC200
" Sml amber glass vials with rubber stopper and green plastic screw cap.
" 1 0 control vials per box, 12 cell foam insert.

Product Usage:
MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
Code Information HEC200: " 616UE, Mfr. Date 2013-02, Exp. 2017-01 " 652UE, Mfr. Date 2013-07, Exp. 2017-07 " 720UE, Mfr. Date 2014-08, Exp. 2018-07 HNC200: " 858UN, Mfr. Date 2013-07, Exp. 2018-07 " 941 UN, Mfr. Date 2014-07, Exp. 2018-06
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall		 MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.
FDA Determined
Cause 2		 Under Investigation by firm
Action An technical bulletin/advisory was issued to alert users of the MedTest DX Chemistry Controls catalog numbers HNC200 and HEC200 that revisions have been made for the assigned ranges when used with Arkray Spotchem - EZ Dry Chemistry Analyzer. Customer label corrections were sent to customers who purchased the affected control lots on the following dates: " 10/23/14 technical bulletin HEC200101014 via US mail. " 12/3/14 technical bulletin HNCHEC200120114 via US mail. " 4/6/15 technical bulletin HNCHEC200031015 via US mail. " 5/29/15 technical bulletin HNC200052115 via US mail and email.
Quantity in Commerce 10260 volume vials
Distribution US Nationwide Distribution
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 = JJY and Original Applicant = RANDOX LABORATORIES, LTD.
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