FDA recall Z-2965-2026

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.

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.¿¿¿¿¿

Key facts

Status

Ongoing

Initiation date

2026-07-13

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caernarfon, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2026