Devices

Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument

Model / Serial
All lots between 12/18/03 and 4/16/09.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 || Cont. || 1 FIIG20210A MD Mix, 1 x 78 uL || 2. FIIG20210A R mix, 1 x 78 uL || 3. FIIG20210A CT, 1 x 50 uL || 5, FIIG20210A DIL 1 x 1 mL || Manufactured in Germany || Distributed by Roche Diagnostics, Indianapolis, IN
Manufacturer
Roche Molecular Systems, Inc.
1 Event
- Recall of Device Recall FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument

Manufacturer

Roche Molecular Systems, Inc.

Manufacturer Address
Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Somerville NJ 08876-3733
Manufacturer Parent Company (2017)
Roche Holding AG
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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