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).
FDA Recall Z-2316-2017 · Posted None
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Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeJJY
Date Initiated2014-10-23
Date Terminated2017-11-17
Product Quantity10260 volume vials
Reason for Recall
MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200)
and Level 2 (HEC200) control values are outside of specification.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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