Devices

Device Recall Simplastin L

Model / Serial
Product #259553, Lot #161642, 161643 and 161690.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
Product Description
Simplastin¿ L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
Manufacturer
bioMerieux
1 Event
- Recall of Device Recall Simplastin L

Manufacturer

bioMerieux

Manufacturer Address
bioMerieux, 100 Rodolphe Street, Building 1300, Durham NC 27712
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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