ADVIA Centaur Systems TSH3 Ultra

Model: 06491072 06491080, Affected: Kit lots ending in 266, 267, 269, 270, 271, 272 and 273

In-vitro diagnostics - equipment / products for clinical chemistry

Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 273 18 November 2014

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.

ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test || Catalog Number: 06491072; Siemens Material Number: 10282378. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.

ADVIA Centaur Systems TSH3 Ultra 2500 tests || Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. || Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.

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.

ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). || Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).