System, Test, Radioallergosorbent (rast) Immunological
Immunology · 21 CFR 866.5750
Recent MDR events
60 adverse event reports on file
- IMMULITE 2000 3G ALLERGY SPECIFIC IGE UNIVERSAL KITJun 10, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00110
- PHADIA 250Mar 20, 2026InjuryPhadia Ab3004973408-2026-00001
- IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITFeb 12, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00037
- IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITNov 14, 2025MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2025-00207
- IMMULITE 2000 OAK MIX SPECIFIC ALLERGENOct 21, 2025MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2025-00191
- IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITOct 16, 2025MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2025-00185
- IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KITOct 16, 2025MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2025-00186
- PHADIA 1000Oct 15, 2025MalfunctionPhadia Ab3004973408-2025-00002
- PHADIA 1000 INSTRUMENTJun 30, 2025InjuryPhadia Ab3004973408-2025-00001
- IMMULITE® 2000 3GALLERGY SPECIFIC IGEDec 11, 2024MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2024-00496
Event type breakdown
Recalls
27 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Allergy Panel Test (IgE)
Distribution without premarket approval/clearance.
Z-0759-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Sensitivity Test Large
Distribution without premarket approval/clearance.
Z-0760-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Sensitivity Test Medium
Distribution without premarket approval/clearance.
Z-0761-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Sensitivity Test Small
Distribution without premarket approval/clearance.
Z-0762-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Allergy Test IgE
Distribution without premarket approval/clearance.
Z-0769-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Allergy test Small
Distribution without premarket approval/clearance.
Z-0803-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Intolerance Test Large
Distribution without premarket approval/clearance.
Z-0806-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Intolerance Test Medium
Distribution without premarket approval/clearance.
Z-0807-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Food Intolerance Test Small
Distribution without premarket approval/clearance.
Z-0808-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Pet Allergy Test
Distribution without premarket approval/clearance.
Z-0813-2026 · View FDA record ↗
Registered firms
123 firms currently registered for this product code
Phadia Us Inc.
Portage, MI, US
Hycor Biomedical
GARDEN GROVE, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Hitachi High-tech Corp., Musashimurayama Center
Musashimurayama Tokyo, JP
Phadia Ab
Uppsala, SE
Scientific Supplies & Technology, Inc.
Doral, FL, US
Medicatec Inc.
Yashio-shi Saitama, JP
Diamond Diagnostics Inc.
Budapest, HU
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Canon Medical Diagnostics Usa, Inc.
MOUNTAIN VIEW, CA, US
510(k) clearances
268 clearances for this product code
- Hycor BiomedicalJul 24, 2026
K261027 · NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut
- Hycor BiomedicalJul 21, 2026
K260591 · NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut
- Hycor BiomedicalJun 18, 2026
K260280 · NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg
- Hycor BiomedicalMay 15, 2026
K260059 · NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)
- Hycor BiomedicalJan 16, 2026
K252775 · NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
- Hycor BiomedicalDec 23, 2025
K252493 · NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
- Hycor BiomedicalApr 23, 2025
K242531 · NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
- Phadia ABAug 3, 2022
K212181 · ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed