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 |
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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 = JJY
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