Devices

Device Recall Dimension Total Prostate Specific Antigen Flex Reagent Cartridge

Model / Serial
Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE
Product Description
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
Manufacturer
Siemens Healthcare Diagnostics Inc.
1 Event
- Recall of Device Recall Dimension Total Prostate Specific Antigen Flex Reagent Cartridge

Manufacturer

Siemens Healthcare Diagnostics Inc.

Manufacturer Address
Siemens Healthcare Diagnostics Inc., 500 GBC Drive, Mailstop 514, P. O. Box 6101, Newark DE 19714-6101
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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