FDA Medical devices recall ·
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen recall
- Recall number
- Z-2965-2026
- Date
- (initiated July 13, 2026)
- Company / brand
- Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy, Caernarfon, United Kingdom - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 24 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
Why was it recalled?
Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: D387/UDI: 00630414976891
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.¿¿¿¿¿
States: Florida New Jersey New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2965-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.