Devices

The Dimension TNI Flex reagent cartridge

Model / Serial
Lot# FD0110 Exp# 04/20/2010, Lot#FD0141, EXP# 05/21/2010, Lot# ED0155, EXP# 06/04/2010, Lot# EA0227, EXP# 08/15/2010, Lot# EB0247, EXP#09/04/2010, Lot# FA2096, EXP#10/23/2010, Lot#FC0310, EXP# 11/06/2010, Lot# FA0330, EXP# 11/26/2010.
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 TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of The Dimension TNI Flex reagent cartridge

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

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