Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) Recalled by Medtest Holdings, Inc. Due to MedTest DX Assayed Human Multi Sera Control Level...

Date: October 23, 2014
Company: Medtest Holdings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtest Holdings, Inc. directly.

Affected Products

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).

Quantity: 10260 volume vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtest Holdings, Inc.

Medtest Holdings, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report