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Devices
Device Recall Stratus CS Acute Care Troponin I TestPak
Model / Serial
Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
Product Description
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Manufacturer
Dade Behring, Inc.
1 Event
Recall of Device Recall Stratus CS Acute Care Troponin I TestPak
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Manufacturer
Dade Behring, Inc.
Manufacturer Address
Dade Behring, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
English
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