Devices

Device Recall Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)

Model / Serial
Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.
Product Description
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)

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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