Home / Recalls / Medtest Holdings, Inc. / Z-2316-2017

Z-2316-2017 Class III Terminated

Recalled by Medtest Holdings, Inc. — Canton, MI

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
October 23, 2014
Termination Date
November 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10260 volume vials

Product Description

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).

Reason for Recall

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.

Distribution Pattern

US Nationwide Distribution

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

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