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Devices
Device Recall MDA Simplastin L
Model / Serial
Product #252555, Lot #500065, 500066 and 500067
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
MDA¿ Simplastin¿ L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
Manufacturer
bioMerieux
1 Event
Recall of Device Recall MDA Simplastin L
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Manufacturer
bioMerieux
Manufacturer Address
bioMerieux, 100 Rodolphe Street, Building 1300, Durham NC 27712
Source
USFDA
Language
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