Medtest Holdings, Inc. recalls MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with ru…

Recall date

October 23, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2316-2017

FDA classification

Class III

Brand / firm

Medtest Holdings, Inc.

Sold / distributed

US Nationwide Distribution

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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).