Devices

Device Recall BC Thrombin OENA11

Model / Serial
Lot 540624, Lot 540625, and Lot 540626
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
Product Description
BC Thrombin Reagent . Thrombin Time Test
Manufacturer
Dade Behring , Inc.
1 Event
- Recall of Device Recall BC Thrombin OENA11

Manufacturer

Dade Behring , Inc.

Manufacturer Address
Dade Behring , Inc., Rte 896, Glasgow Business Community, Newark DE 19702
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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