Devices

Immunoassay Premium Controls

Model / Serial
Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Distribution US nationwide.
Product Description
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Manufacturer
Randox Laboratories
1 Event
- Recall of Immunoassay Premium Controls

Manufacturer

Randox Laboratories

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

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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.

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