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Devices
The Dimension FT4L Flex reagent cartridge
Model / Serial
Lot# EC0122 Exp# 05/22/2010, Lot# EG0173, EXP# 06/22/2010, Lot# FA0219, EXP# 08/07/2010, Lot# FA0249, EXP# 09/06/2010, Lot# FB02626, EXP# 09/19/2010.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia.
Product Description
The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of The Dimension FT4L Flex 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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