International safety notice
Technical name: Universal IgE Specific Allergen Kit 3g IMMULITE 2000; ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK-MB IMMULITE 2000; EPO IMMULITE; GASTRINA IMMULITE / IMMULITE 1000; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMINA B12 IMMULITE/IMMULITE1000
Brazil / Anvisa · BRA · Jan 11, 2018
Key facts
| Title | Technical name: Universal IgE Specific Allergen Kit 3g IMMULITE 2000; ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK-MB IMMULITE 2000; EPO IMMULITE; GASTRINA IMMULITE / IMMULITE 1000; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMINA B12 IMMULITE/IMMULITE1000 |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: IMMULITE 2000 Universal Specific Allergen IgE Kit 3g ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK - MB IMMULITE 2000; EPO IMMULITE; EPO IMMULITE 2000; ACIDO FOLICO IMMULITE 2000; GASTRINA IMMULITE / IMMULITE 1000; GASTRINA IMMULITE 2000; OM - MA IMMULITE; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMINA B12 IMMULITE/IMMULITE1000 Technical name: Universal IgE Specific Allergen Kit 3g IMMULITE 2000; ANTI-HBc IMMULITE 2000; BR-MA (CA15-3) IMMULITE; BR-MA (15.3) Immulite 2000; CEA IMMULITE; CEA IMMULITE 2000; CK-MB IMMULITE; CK-MB IMMULITE 2000; EPO IMMULITE; GASTRINA IMMULITE / IMMULITE 1000; OM-MA IMMULITE 2000; THYROGLOBULIN IMMULITE; THYROGLOBULIN IMMULITE 2000; VITAMINA B12 IMMULITE/IMMULITE1000 ANVISA registration number: 10345160975 10345161104 10345160914 10345160747 10345160812 10345160902 10345161894 10345160745 10345160756 10345160827 10345160712 10345160718 10345160701 10345160916 10345161009 10345160877 10345160871 10345160825 Risk class (Consecutive order of registration number): II IV III III III III III III II II II II II III III II II II Affected model: N/A. Affected serial numbers: REAG ALERGIA UNIV IGE 600T (IMM2000): 447; 448; 450; 451; 453; 456; 457; 458; 459; 461; 462; 465; 466; 468; 469. FOLIC ACID REAGENT 200T (IMM2000): 494; FOLIC ACID REAGENT 600T (IMM2000): 492; REAGENTE ANTI-HBC 200T (IMM2000): 577; 578; 579; 580 REAGENTE BR-MA 15.3 200T (IMM2000): 262; 263; 264; 265; 266. CEA 100T REAGENTS (IMM1000): 353; CEA 200T REAGENTS (IMM2000): 307; CEA 600T REAGENTS (IMM2000): 307; REAGENTE CKMB 100T (IMM1000): 342; 343; 344; 345. REAGENT CKMB 200T (IMM2000): 238; EPO MONO REAGENT (IMM1000): 343; REAGENTE EPO MONO (IMM2000): 246; 247; 248; 249; 250; 251; 252. GASTRINA REAGENT 200T (IMM2000): 248; REAGENTS OM-MA CA125 100T (IMM1000): 209; REAGENTE OM-MA CA125 200T (IMM2000): 285; 286; 287; 289. REAGENTE TIROGLOBULINA 100T (IMM1000): 286; 287; 288; 289; 290. THYROGLOBULIN REAGENT 200T (IMM2000): 340; REAGENTE VITAMINA B-12 100T (IMM1000): 336; 337; 338; 339; 340; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP FABRICANTE SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD GLYN RHONWN LLANBERIS CAERNARFON GWYNEDD LL55 4EL REINO UNIDO |
| Models | 10345160747, 10345160827, IMM2000, 10345160877, 10345160916, 10345160975, IMMULITE1000, 10345160745, 10345160701, 10345160756, 10345160902, 10345160871 and 11 more |
| Date | Jan 11, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1