Advia

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).

Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

Reagent Lot Numbers: 056301 and 56302 Kit Lot Number/Exp. Date: REF 10492369- 500 Tests 61639301 09 Nov 2011 REF 1 0493615 - 500 Tests 63607301 09 Nov 2011 68004301 09 Nov 2011 70229301 09 Nov 2011 74126301 09Nov2011 REF 10493616-500 Tests 62645302 09 Nov 2011 66612302 09 Nov 2011 74129302 09 Nov 2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).

Calibrator Lot Number: C5601 and C5602 Kit Lot Number/Exp. Date: 61405A01 27 Oct 2011 66517A02 27 Oct 2011 66611A02 27 Oct 2011 71997C02 27 Oct 2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. || For in vitro diagnostic use in calibrating Intact PTH assays.

Calibrator Lot Numbers: C5601, C5602 and C5603 Kit Lot Number/Exp. Date: REF 10492387 - 6 pk  61404A01 27 Oct 2011 66516A02 27 Oct 2011 66610A02 27 Oct 2011 67824B02 27 Oct 2011 70657B02 27 Oct 2011 74448A03 13 Jul2012  REF 10630628 - 6 pk 668748B02 27 Oct 2011 68015B02 27 Oct 2011 72400B02 27 Oct 2011 74449B02 27 Oct 2011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. || For in vitro diagnostic use in calibrating Intact PTH assays.