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Manufacturers
TEM Systems Inc
Manufacturer Address
TEM Systems Inc, 4309 Emperor Blvd Ste 100, Durham NC 27703-8069
Source
USFDA
1 Event
Recall of ROTROL P
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One device in the database
ROTROL P
Model / Serial
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
One manufacturer with a similar name
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TEM Systems Inc
Manufacturer Address
TEM Systems Inc, 3210 E Nc Hwy 54, Durham NC 27709
Manufacturer Parent Company (2017)
Tem Systems Inc.
Source
USFDA
Language
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