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Devices
Device Recall Dimension TSH Flex Reagent Cartridge
Model / Serial
Per recall strategy.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
Product Description
Dimension TSH Flex Reagent Cartridge (REF RF412). || Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Manufacturer
Siemens Healthcare Diagnostics, Inc
1 Event
Recall of Device Recall Dimension TSH Flex Reagent Cartridge
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Manufacturer
Siemens Healthcare Diagnostics, Inc
Manufacturer Address
Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA
Language
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