International Medical Devices Database

Manufacturer Address
Abbott Health Products, Inc., Hwy 2 Km 58.0, Cruze Davila, Barceloneta PR 00617
Source
USFDA
1 Event
- Recall of Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls

One device in the database

Device Recall TDx/TDxFlx Cyclosporine Monoclonal Whole Blood Calibrators & Controls

Model / Serial
Lot 18229Q100 (exp 8/26/2006) Lot 18230Q100 (exp 10/05/2006)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Puerto Rico, Hawaii, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Dominican Republic, Canada, Germany, Japan , Singapore, India, Taiwan, Thailand, Korea, Australia, Honduras, and Panama,
Product Description
In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. || TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2).

One manufacturer with a similar name

Learn more about the data here

Abbott Health Products, Inc.

Manufacturer Address
Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
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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