Devices

Device Recall Lipase

Model / Serial
Lot numbers: 428000, 404175, and 404245
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Product Description
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 || Product Usage: || For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Manufacturer
Randox Laboratories Ltd.
1 Event
- Recall of Device Recall Lipase

Manufacturer

Randox Laboratories Ltd.

Manufacturer Address
Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
Manufacturer Parent Company (2017)
Randox Holdings Limited
Source
USFDA

One device with a similar name

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Device Recall Lipase

Model / Serial
List Numbers: 7D80-20 and 7D80-30; Control Numbers: 37033HW00, 33032HW00, 30053HW00, 47048HW00, 45067HW00, 43002HW00, 42016HW00 & 42010HW00
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
Product Description
Clinical Chemistry Lipase, List Numbers: 7D80-20 and 7D80-30
Manufacturer
Abbott Laboratories Inc.

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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.

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