Devices

MedTest DX Assayed Human Multi Sera Control

Model / Serial
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
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution
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).
Manufacturer
Medtest Holdings, Inc.
1 Event
- Recall of MedTest DX Assayed Human Multi Sera Control

Manufacturer

Medtest Holdings, Inc.

Manufacturer Address
Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
Manufacturer Parent Company (2017)
Medtest Holdings Inc
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)