FDAFDA recall Z-2965-2026 · Aug 26, 2026
Siemens Healthcare Diagnostics Products Ltd.: Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD recall
Recall found
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Reason for recall
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: D387/UDI: 00630414976891
- Quantity
- 24 units
- 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.¿¿¿¿¿
- Recalling firm
- Siemens Healthcare Diagnostics Products Ltd., Caernarfon
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-13
Source: openFDA enforcement record Z-2965-2026 · search recall number Z-2965-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.