Can cause harm that is usually temporary.

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly

Check the device or its packaging for

Why

Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.

Distributed

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.¿¿¿¿¿

Company

Siemens Healthcare Diagnostics Products Ltd.

Announced

26 August 2026This is the date the recall was announced. A company may have started it weeks earlier.

Recall began

13 July 2026

Source: FDA record Z-2965-2026 · retrieved 14 August 2026