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Devices
Device Recall Dimension EXL LOCI Module TSHL 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 EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). || Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Manufacturer
Siemens Healthcare Diagnostics, Inc
1 Event
Recall of Device Recall Dimension EXL LOCI Module TSHL 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
English
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