IMMULITE Systems

Model: , Affected: ADVIA Centaur Progesterone1 - All Lots, Dimension Vista LOCI Progesterone2 - All Lots, IMMULITE/IMMULITE 1000 Progesterone - All Lots, IMMULITE 2000 Progesterone3 - All Lots

in-vitro_medical_device

In-vitro diagnostics - immunological products

In-vitro diagnostics - equipment / products for clinical chemistry

Per recall strategy.

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). || Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).