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Devices
The Dimension FTSHL Flex reagent cartridge
Model / Serial
Lot# FJ0103 Exp# 04/12/2010, Lot# EE0166, EXP# 06/15/2010, Lot# EA0185, EXP# 07/04/2010, Lot# FA0199, EXP# 07/18/2010, Lot# EC0266, EXP#08/14/2010, Lot# FC0262, EXP#09/19/2010, Lot#FB1068, EXP# 03/09/2011.
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 TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
Recall of The Dimension FTSHL 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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