Devices

Immunoassay Premium Plus Controls

Model / Serial
Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Distribution US nationwide.
Product Description
Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Manufacturer
Randox Laboratories
1 Event
- Recall of Immunoassay Premium Plus Controls

Manufacturer

Randox Laboratories

Manufacturer Address
Randox Laboratories, 515 Industrial Blvd, Kearneysville WV 25430-2778
Manufacturer Parent Company (2017)
Randox Holdings Limited
Source
USFDA

One device with a similar name

Learn more about the data here

Immunoassay Premium Plus Controls

Model / Serial
Product Description
Randox Laboratories: Immunoassay Premium Plus Controls
Manufacturer
Randox Laboratories

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)