Siemens Healthcare Diagnostics Products Ltd. recalls Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF
- Recalling company
- Siemens Healthcare Diagnostics Products Ltd.
- Product
- Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
- Reason
- Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 13, 2026
- Reported
- Aug 26, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NJ, NY and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿
- Status
- Ongoing
- Quantity
- 478 units
- Lot / codes
- Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807
- Company location
- Caernarfon
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2966-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2966-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.