Siemens Healthcare Diagnostics Products, Ltd.

• CGR — Clinical Chemistry2 devices
• DHB — Immunology1 device
• LTK — Immunology1 device
• MOI — Immunology1 device

• Z-2966-2026 — Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnlyClass II·Ongoing·2026-07-13
• Z-2965-2026 — Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnlyClass II·Ongoing·2026-07-13

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Code DHB·2026-09-04
• K233946 — IMMULITE® 2000 BR-MACode MOI·2024-03-13
• K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MACode LTK·2023-09-08
• K202826 — IMMULITE® 2000 CortisolCode CGR·2021-01-15
• K203270 — IMMULITE/IMMULITE® 1000 CortisolCode CGR·2021-01-15