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Device Recall Dimension(R) EZCR Flex(R) Reagent Cartridge
Model / Serial
Catalog number DF270B - Lot numbers BD1008, CD1050, FA1081 and GA1190.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution.
Product Description
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of Device Recall Dimension(R) EZCR Flex(R) Reagent Cartridge
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Manufacturer
Siemens Healthcare Diagnostics, Inc.
Manufacturer Address
Siemens Healthcare Diagnostics, 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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